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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K080602
Device Name AUDICOR SENSOR, MODELS: 2.0, 3.0
Applicant
Inovise Medical, Inc.
10565 SW Nimbus Ave.
Suite 100
Portland,  OR  97223
Applicant Contact KENDRA RATHKEY
Correspondent
Inovise Medical, Inc.
10565 SW Nimbus Ave.
Suite 100
Portland,  OR  97223
Correspondent Contact KENDRA RATHKEY
Regulation Number870.2360
Classification Product Code
DRX  
Subsequent Product Code
DQD  
Date Received03/03/2008
Decision Date 09/25/2008
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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