PROCARE MONITOR B20


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

Correspodent Contact robert casarsa
Regulation Number 870.1025
Classification Product Code
MHX  
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