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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 K030316
Device Name AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
Applicant
INOVISE MEDICAL, INC.
1025 INDUSTRIAL PKWY.
SUITE C
NEWBERG,  OR  97132
Applicant Contact KENDRA RATHKEY
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact JOHN SO
Regulation Number870.2360
Classification Product Code
DRX  
Subsequent Product Code
DQD  
Date Received01/30/2003
Decision Date 08/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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