The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for B&f Medical Oxygen Reg Mecical Oxy Compress Gas Reg.
| Device ID | K942645 |
| 510k Number | K942645 |
| Device Name: | B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG |
| Classification | Gauge, Gas Pressure, Cylinder/pipeline |
| Applicant | B & F MEDICAL PRODUCTS, INC. WASHINGTON HARBOUR 3000 K STREET, N.W. SUITE 500 Washington, DC 20007 -5109 |
| Contact | Ilene Knable Gotts |
| Correspondent | Ilene Knable Gotts B & F MEDICAL PRODUCTS, INC. WASHINGTON HARBOUR 3000 K STREET, N.W. SUITE 500 Washington, DC 20007 -5109 |
| Product Code | BXH |
| CFR Regulation Number | 868.2610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1994-07-27 |