Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K131032 |
Device Name |
PHILIPS SURESIGNS CENTRAL |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
MARY KRUITWAGEN |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
MARY KRUITWAGEN |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 04/12/2013 |
Decision Date | 08/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|