TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
Subpart A - General Provisions
§ 868.1 - Scope.
§ 868.3 - Effective dates of requirement for premarket approval.
§ 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B - Diagnostic Devices
§ 868.1030 - Manual algesimeter.
§ 868.1040 - Powered algesimeter.
§ 868.1075 - Argon gas analyzer.
§ 868.1100 - Arterial blood sampling kit.
§ 868.1120 - Indwelling blood oxyhemoglobin concentration analyzer.
§ 868.1150 - Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
§ 868.1170 - Indwelling blood hydrogen ion concentration (pH) analyzer.
§ 868.1200 - Indwelling blood oxygen partial pressure (PO2) analyzer.
§ 868.1400 - Carbon dioxide gas analyzer.
§ 868.1430 - Carbon monoxide gas analyzer.
§ 868.1500 - Enflurane gas analyzer.
§ 868.1505 - Ventilatory electrical impedance tomograph.
§ 868.1575 - Gas collection vessel.
§ 868.1620 - Halothane gas analyzer.
§ 868.1640 - Helium gas analyzer.
§ 868.1670 - Neon gas analyzer.
§ 868.1690 - Nitrogen gas analyzer.
§ 868.1700 - Nitrous oxide gas analyzer.
§ 868.1720 - Oxygen gas analyzer.
§ 868.1730 - Oxygen uptake computer.
§ 868.1750 - Pressure plethysmograph.
§ 868.1760 - Volume plethysmograph.
§ 868.1780 - Inspiratory airway pressure meter.
§ 868.1800 - Rhinoanemometer.
§ 868.1840 - Diagnostic spirometer.
§ 868.1850 - Monitoring spirometer.
§ 868.1860 - Peak-flow meter for spirometry.
§ 868.1870 - Gas volume calibrator.
§ 868.1880 - Pulmonary-function data calculator.
§ 868.1890 - Predictive pulmonary-function value calculator.
§ 868.1900 - Diagnostic pulmonary-function interpretation calculator.
§ 868.1910 - Esophageal stethoscope.
§ 868.1920 - Esophageal stethoscope with electrical conductors.
§ 868.1930 - Stethoscope head.
§ 868.1965 - Switching valve (ploss).
§ 868.1975 - Water vapor analyzer.
Subpart C - Monitoring Devices
§ 868.2025 - Ultrasonic air embolism monitor.
§ 868.2300 - Bourdon gauge flowmeter.
§ 868.2320 - Uncompensated thorpe tube flowmeter.
§ 868.2340 - Compensated thorpe tube flowmeter.
§ 868.2350 - Gas calibration flowmeter.
§ 868.2375 - Breathing frequency monitor.
§ 868.2377 - Apnea monitor.
§ 868.2380 - Nitric oxide analyzer.
§ 868.2385 - Nitrogen dioxide analyzer.
§ 868.2450 - Lung water monitor.
§ 868.2480 - Cutaneous carbon dioxide (PcCO2) monitor.
§ 868.2500 - Cutaneous oxygen (PcO2) monitor.
§ 868.2550 - Pneumotachometer.
§ 868.2600 - Airway pressure monitor.
§ 868.2610 - Gas pressure gauge.
§ 868.2620 - Gas pressure calibrator.
§ 868.2700 - Pressure regulator.
§ 868.2775 - Electrical peripheral nerve stimulator.
§ 868.2875 - Differential pressure transducer.
§ 868.2885 - Gas flow transducer.
§ 868.2900 - Gas pressure transducer.
Subparts D-E [Reserved]
Subpart F - Therapeutic Devices
§ 868.5090 - Emergency airway needle.
§ 868.5095 - Retrograde intubation device.
§ 868.5100 - Nasopharyngeal airway.
§ 868.5105 - External negative pressure airway aid.
§ 868.5110 - Oropharyngeal airway.
§ 868.5115 - Device to relieve acute upper airway obstruction.
§ 868.5120 - Anesthesia conduction catheter.
§ 868.5130 - Anesthesia conduction filter.
§ 868.5140 - Anesthesia conduction kit.
§ 868.5150 - Anesthesia conduction needle.
§ 868.5160 - Gas machine for anesthesia or analgesia.
§ 868.5165 - Nitric oxide administration apparatus.
§ 868.5170 - Laryngotracheal topical anesthesia applicator.
§ 868.5180 - Rocking bed.
§ 868.5220 - Blow bottle.
§ 868.5240 - Anesthesia breathing circuit.
§ 868.5250 - Breathing circuit circulator.
§ 868.5260 - Breathing circuit bacterial filter.
§ 868.5270 - Breathing system heater.
§ 868.5273 - Positive airway pressure delivery system.
§ 868.5280 - Breathing tube support.
§ 868.5300 - Carbon dioxide absorbent.
§ 868.5310 - Carbon dioxide absorber.
§ 868.5320 - Reservoir bag.
§ 868.5330 - Breathing gas mixer.
§ 868.5340 - Nasal oxygen cannula.
§ 868.5350 - Nasal oxygen catheter.
§ 868.5365 - Posture chair for cardiac or pulmonary treatment.
§ 868.5375 - Heat and moisture condenser (artificial nose).
§ 868.5400 - Electroanesthesia apparatus.
§ 868.5420 - Ether hook.
§ 868.5430 - Gas-scavenging apparatus.
§ 868.5440 - Portable oxygen generator.
§ 868.5450 - Respiratory gas humidifier.
§ 868.5454 - High flow humidified oxygen delivery device.
§ 868.5460 - Therapeutic humidifier for home use.
§ 868.5470 - Hyperbaric chamber.
§ 868.5480 - Isocapnic ventilation device.
§ 868.5530 - Flexible laryngoscope.
§ 868.5540 - Rigid laryngoscope.
§ 868.5550 - Anesthetic gas mask.
§ 868.5560 - Gas mask head strap.
§ 868.5570 - Nonrebreathing mask.
§ 868.5580 - Oxygen mask.
§ 868.5590 - Scavenging mask.
§ 868.5600 - Venturi mask.
§ 868.5620 - Breathing mouthpiece.
§ 868.5630 - Nebulizer.
§ 868.5640 - Medicinal nonventilatory nebulizer (atomizer).
§ 868.5650 - Esophageal obturator.
§ 868.5655 - Portable liquid oxygen unit.
§ 868.5665 - Powered percussor.
§ 868.5675 - Rebreathing device.
§ 868.5690 - Incentive spirometer.
§ 868.5700 - Nonpowered oxygen tent.
§ 868.5710 - Electrically powered oxygen tent.
§ 868.5720 - Bronchial tube.
§ 868.5730 - Tracheal tube.
§ 868.5740 - Tracheal/bronchial differential ventilation tube.
§ 868.5750 - Inflatable tracheal tube cuff.
§ 868.5760 - Cuff spreader.
§ 868.5770 - Tracheal tube fixation device.
§ 868.5780 - Tube introduction forceps.
§ 868.5790 - Tracheal tube stylet.
§ 868.5795 - Tracheal tube cleaning brush.
§ 868.5800 - Tracheostomy tube and tube cuff.
§ 868.5810 - Airway connector.
§ 868.5820 - Dental protector.
§ 868.5830 - Autotransfusion apparatus.
§ 868.5860 - Pressure tubing and accessories.
§ 868.5870 - Nonrebreathing valve.
§ 868.5880 - Anesthetic vaporizer.
§ 868.5895 - Continuous ventilator.
§ 868.5905 - Noncontinuous ventilator (IPPB).
§ 868.5915 - Manual emergency ventilator.
§ 868.5925 - Powered emergency ventilator.
§ 868.5935 - External negative pressure ventilator.
§ 868.5955 - Intermittent mandatory ventilation attachment.
§ 868.5965 - Positive end expiratory pressure breathing attachment.
§ 868.5975 - Ventilator tubing.
§ 868.5995 - Tee drain (water trap).
Subpart G - Miscellaneous
§ 868.6100 - Anesthetic cabinet, table, or tray.
§ 868.6175 - Cardiopulmonary emergency cart.
§ 868.6225 - Nose clip.
§ 868.6250 - Portable air compressor.
§ 868.6400 - Calibration gas.
§ 868.6700 - Anesthesia stool.
§ 868.6810 - Tracheobronchial suction catheter.
§ 868.6820 - Patient position support.
§ 868.6885 - Medical gas yoke assembly.
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