Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K021347 |
Device Name |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. MS 0490 |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
DENISE HALEY |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. MS 0490 |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
DENISE HALEY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 04/29/2002 |
Decision Date | 05/07/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|