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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K102239
Device Name CARESCAPE MONITOR B650
Applicant
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Applicant Contact PAIVI ROIHA
Correspondent
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Correspondent Contact PAIVI ROIHA
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/09/2010
Decision Date 10/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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