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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K070136
Device Name AUDICOR 200 SYSTEM, MODELS 200D AND 200S
Applicant
INOVISE MEDICAL, INC.
10565 SW NIMBUS AVE.
SUITE 100
PORTLAND,  OR  97223
Applicant Contact STEVE HESLER
Correspondent
INOVISE MEDICAL, INC.
10565 SW NIMBUS AVE.
SUITE 100
PORTLAND,  OR  97223
Correspondent Contact STEVE HESLER
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQD  
Date Received01/16/2007
Decision Date 04/13/2007
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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