BYK
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tent, Oxygen, Electrically Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5710
- Medical specialty
- Anesthesiology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1993: 1 · 1998: 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 |
|---|---|---|
| CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT (K941547) | Allied Healthcare Products, Inc. | 1995-03-01 |
| LUNG DIFFUSION GAS MIXTURE (K882817) | Swisco, Inc. | 1988-08-15 |
| DISS FEMALE AIR ADAPTOR (K813235) | Timeter Instrument Corp. | 1981-12-08 |
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Every clearance here is in the API, with alerts when new ones post.