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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K872869
Device Name STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
Applicant
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Applicant Contact MICHAEL S BARTLETT
Correspondent
Labeltape Meditect, Inc.
4275 Airwest Dr., SE
P.O. Box 8823
Grand Rapids,  MI  49508
Correspondent Contact MICHAEL S BARTLETT
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/21/1987
Decision Date 11/04/1987
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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