| 510(k) Number |
K941462 |
| Device Name |
CARDIOVIT AT-5C |
| Applicant |
| Schiller America, Inc. |
| 3002 Dow Ave., #138 |
|
Tustin,
CA
92780
|
|
| Applicant Contact |
MARKUS MARITZ |
| Correspondent |
| Schiller America, Inc. |
| 3002 Dow Ave., #138 |
|
Tustin,
CA
92780
|
|
| Correspondent Contact |
MARKUS MARITZ |
| Classification Product Code |
|
| Date Received | 03/24/1994 |
| Decision Date | 05/19/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|