Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K131414 |
Device Name |
CARESCAPE MONITOR B850 |
Applicant |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Applicant Contact |
JOEL KENT |
Correspondent |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Correspondent Contact |
JOEL KENT |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/16/2013 |
Decision Date | 08/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|