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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
Recalls CDRH Recalls
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