| Device Classification Name |
Chamber, Patient Isolation
|
| 510(k) Number |
K896721 |
| Device Name |
MODEL 7-AT TREATMENT CHAMBER |
| Applicant |
| J. H. Emerson Co. |
| 22 Cottage Park Ave. |
|
Cambridge,
MA
02140
|
|
| Applicant Contact |
GEORGE P EMERSON |
| Correspondent |
| J. H. Emerson Co. |
| 22 Cottage Park Ave. |
|
Cambridge,
MA
02140
|
|
| Correspondent Contact |
GEORGE P EMERSON |
| Regulation Number | 880.5450 |
| Classification Product Code |
|
| Date Received | 11/28/1989 |
| Decision Date | 01/22/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|