| Device Classification Name |
Gauge, Gas Pressure, Cylinder/Pipeline
|
| 510(k) Number |
K942645 |
| Device Name |
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG |
| Applicant |
| B & F Medical Products, Inc. |
| Washington Harbour |
| 3000 K St., NW Suite 500 |
|
Washington,
DC
20007 -5109
|
|
| Applicant Contact |
ILENE KNABLE GOTTS |
| Correspondent |
| B & F Medical Products, Inc. |
| Washington Harbour |
| 3000 K St., NW Suite 500 |
|
Washington,
DC
20007 -5109
|
|
| Correspondent Contact |
ILENE KNABLE GOTTS |
| Regulation Number | 868.2610 |
| Classification Product Code |
|
| Date Received | 06/03/1994 |
| Decision Date | 07/27/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|