NPF — Monitor, Apnea, Home Use Class II
FDA product code NPF covers "Monitor, Apnea, Home Use", a Class II medical device regulated under 21 CFR 868.2377. 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
- NPF
- Device Class
- Class II
- Regulation Number
- 868.2377
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
Same as the identification for product code FLS, just add home use