| 510(k) Number |
K980495 |
| Device Name |
MUSE CARDIOVASCULAR INFORMATION SYSTEM |
| Applicant |
| Marquette Medical Systems, Inc. |
| 8200 W. Tower Ave. |
|
Milwaukee,
WI
53223
|
|
| Applicant Contact |
KRISTIN PABST |
| Correspondent |
| Marquette Medical Systems, Inc. |
| 8200 W. Tower Ave. |
|
Milwaukee,
WI
53223
|
|
| Correspondent Contact |
KRISTIN PABST |
| Classification Product Code |
|
| Date Received | 02/09/1998 |
| Decision Date | 05/07/1998 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|