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U.S. Department of Health and Human Services

Product Classification
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Device airway monitoring system
Regulation Description Tracheal tube.
Definition The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip
Physical State The device is comprised of a small monitor and a sterile, single use adapter.
Technical Method The device uses acoustic reflection technologyto generate an audible sound signal from a speaker and two microphones that receive acoustic reflections that arise from within the ETT tube
Target Area The device is placed in-line between the ventilator circuit and the proximal end of the endotracheal tube of a patient who is connected to a ventilator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeOQU
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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