NPF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Apnea, Home Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2377
- Medical specialty
- Anesthesiology
- Flags
- Life-sustaining
- FDA definition
- Same as the identification for product code FLS, just add home use
- Adverse events (MAUDE)
- 2004: 2 · 2009: 5 · 2018: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SMARTMONITOR 2PS (K061256) | Respironics, Inc. | 2006-08-02 |
| SMARTMONITOR 2 PROFESSIONAL SERIES (PS) (K032403) | Respironics, Inc. | 2003-10-27 |
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Every clearance here is in the API, with alerts when new ones post.