Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device noninvasive positive airway pressure system, facility use
Regulation Description Continuous ventilator.
Definition To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.
Physical State A control unit with a breathing circuit and nasal prongs/mask.
Technical Method A continuous flow of airway gas through an underwater seal (bubble CPAP generator) generates positive airway pressure and oscillations which are delivered to the patient interface with a sealing component on the patient’s nose (nasal prongs/mask).
Target Area Lungs
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeSGR
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5895
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-