ISP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Valve, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 2 · 1993: 4 · 1994: 2
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 |
|---|---|---|
| ERGOTEST 40 & 45 (K843855) | Erich Jaeger, Inc. | 1984-11-27 |
Track ISP automatically
Every clearance here is in the API, with alerts when new ones post.