Device Classification Name |
System, Network And Communication, Physiological Monitors
|
510(k) Number |
K161164 |
Device Name |
CareEvent inclusive of the CareEvent Mobile Application accessory |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Applicant Contact |
Theresa Poole |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN ROAD |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
Theresa Poole |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 04/25/2016 |
Decision Date | 06/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|