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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K111159
Device Name HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
Applicant
CARDIO COMM SOLUTIONS, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact JONATHAN WARD
Correspondent
CARDIO COMM SOLUTIONS, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact JONATHAN WARD
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/25/2011
Decision Date 12/22/2011
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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