FCP
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Box, Battery, Pocket
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2002: 1 · 2004: 1
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 |
|---|---|---|
| TELEMETRY POWER PACK MODEL 2 (K891927) | Lucas & Rhea Mfg. | 1990-04-26 |
| BATTERY PACKS (OTHER THAN CV) (K881885) | Dowit Service Co., Inc. | 1988-07-26 |
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Every clearance here is in the API, with alerts when new ones post.