FPF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bottle, Hot/Cold Water
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6085
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1995: 1 · 1997: 4 · 1999: 2 · 2000: 5 · 2002: 3 · 2004: 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 |
|---|---|---|
| 3M COLD/HOT WATER BAG AND WRAP (K791176) | 3M Company | 1979-07-30 |
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Every clearance here is in the API, with alerts when new ones post.