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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 K091594
Device Name HEART-EXERCISE
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact PATRICIA TAIGE
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact PATRICIA TAIGE
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Code
DQK  
Date Received06/02/2009
Decision Date 07/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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