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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 K864690
Device Name ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
Applicant
Multi Biosensors, Inc.
P.O. Box 12264
El Paso,  TX  79913
Applicant Contact DR. S MANOLI
Correspondent
Multi Biosensors, Inc.
P.O. Box 12264
El Paso,  TX  79913
Correspondent Contact DR. S MANOLI
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/02/1986
Decision Date 05/06/1987
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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