BXH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gauge, Gas Pressure, Cylinder/Pipeline
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2610
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2002: 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 |
|---|---|---|
| B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (K942645) | B & F Medical Products, Inc. | 1994-07-27 |
| PRESSURE GAUGE (K853040) | Erie Medical | 1985-10-10 |
| LOW PRESSURE ALARM FOR OXYGEN CYLINDER (K843212) | Hospitak, Inc. | 1984-09-19 |
| MONITOR, GAS MANIFOLD (K770614) | Dynatech Cryomedical Co. | 1977-04-07 |
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Every clearance here is in the API, with alerts when new ones post.