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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 K140096
Device Name HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
Applicant
Hmicro, Inc.
4984 El Camino Real #200
Los Altos,  CA  94022
Applicant Contact KIM TOMPKINS
Correspondent
Hmicro, Inc.
4984 El Camino Real #200
Los Altos,  CA  94022
Correspondent Contact KIM TOMPKINS
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/14/2014
Decision Date 07/24/2014
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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