| 510(k) Number |
K864394 |
| Device Name |
EMERSON 3MV VOLUME VENTILATOR |
| Applicant |
| J. H. Emerson Co. |
| 22 Cottage Park Ave. |
|
Cambridge,
MA
02140
|
|
| Applicant Contact |
GEORGE EMERSON |
| Correspondent |
| J. H. Emerson Co. |
| 22 Cottage Park Ave. |
|
Cambridge,
MA
02140
|
|
| Correspondent Contact |
GEORGE EMERSON |
| Date Received | 11/06/1986 |
| Decision Date | 12/05/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|