BYN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Chair, Posture, For Cardiac And Pulmonary Treatment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5365
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1992: 1 · 1993: 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 |
|---|---|---|
| MODEL 820 TOP=TRAK (K873039) | Sierra Laboratories, Inc. | 1988-02-11 |
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Every clearance here is in the API, with alerts when new ones post.