Device Classification Name |
alarm, blood-pressure
|
510(k) Number |
K133961 |
Device Name |
SURESIGNS VS3, SURESIGNS VS4 |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
GREG LI |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
GREG LI |
Regulation Number | 870.1100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/24/2013 |
Decision Date | 06/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|