| Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
| 510(k) Number |
K023569 |
| Device Name |
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS |
| Applicant |
| Siemens Medical Solutions USA, Inc. |
| 16 Electronics Ave. |
|
Danvers,
MA
01923
|
|
| Applicant Contact |
PENELOPE H GRECO |
| Correspondent |
| Siemens Medical Solutions USA, Inc. |
| 16 Electronics Ave. |
|
Danvers,
MA
01923
|
|
| Correspondent Contact |
PENELOPE H GRECO |
| Regulation Number | 870.1025 |
| Classification Product Code |
|
| Date Received | 10/24/2002 |
| Decision Date | 11/04/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|