Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K122253 |
Device Name |
PROCARE MONITOR B20 |
Applicant |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
8200 WEST TOWER AVE |
MILWAUKEE,
WI
53223
|
|
Applicant Contact |
ROBERT CASARSA |
Correspondent |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
8200 WEST TOWER AVE |
MILWAUKEE,
WI
53223
|
|
Correspondent Contact |
ROBERT CASARSA |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 03/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|