| 510(k) Number |
K843700 |
| Device Name |
ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- |
| Applicant |
| Future Impex Corp. |
| 2076 Deer Park Ave. |
|
Deerpark,
NY
11729
|
|
| Applicant Contact |
MORAD DAVOUDZADEH |
| Correspondent |
| Future Impex Corp. |
| 2076 Deer Park Ave. |
|
Deerpark,
NY
11729
|
|
| Correspondent Contact |
MORAD DAVOUDZADEH |
| Date Received | 09/20/1984 |
| Decision Date | 10/24/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|