SGR — Noninvasive Positive Airway Pressure System, Facility Use Class II
FDA product code SGR covers "Noninvasive Positive Airway Pressure System, Facility Use", a Class II medical device regulated under 21 CFR 868.5895. Submissions are reviewed by the Anesthesiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SGR
- Device Class
- Class II
- Regulation Number
- 868.5895
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.