B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
FDA 510(k) clearance K942645 · decided 1994-07-27
Clearance details
- K-number
- K942645
- Device name
- B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
- Applicant
- B & F Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-03
- Decision date
- 1994-07-27
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- BXH
- Device class
- 1
- Regulation number
- 868.2610
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.