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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K101892
Device Name HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-
Applicant
Heine Optotechnik GmbH & Co. KG
Beim Strohhause 27
Hamburg,  DE 20097
Applicant Contact THOMAS WEBER
Correspondent
Heine Optotechnik GmbH & Co. KG
Beim Strohhause 27
Hamburg,  DE 20097
Correspondent Contact THOMAS WEBER
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/07/2010
Decision Date 08/27/2010
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
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