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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K001349
Device Name CARDIOVISE ECG INTERPRETATIVE SOFTWARE
Applicant
INOVISE MEDICAL, INC.
1025 INDUSTRIAL PKWY.
SUITE C
NEWBERG,  OR  97132
Applicant Contact DEBRA A OLSON
Correspondent
INOVISE MEDICAL, INC.
1025 INDUSTRIAL PKWY.
SUITE C
NEWBERG,  OR  97132
Correspondent Contact DEBRA A OLSON
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/28/2000
Decision Date 07/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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