| Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
| 510(k) Number |
K941037 |
| Device Name |
BNOS MICRO VENT, MODEL AC AND MODEL AO |
| Applicant |
| Reeves Manufactoring |
| 30 E. 9th St. |
|
Frederick,
MD
21701
|
|
| Applicant Contact |
P.J. RICHARDSON |
| Correspondent |
| Reeves Manufactoring |
| 30 E. 9th St. |
|
Frederick,
MD
21701
|
|
| Correspondent Contact |
P.J. RICHARDSON |
| Regulation Number | 868.5915 |
| Classification Product Code |
|
| Date Received | 03/02/1994 |
| Decision Date | 08/18/1994 |
| 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
|
|
|