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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 K122632
Device Name GUAVA II
Original Applicant
CARDIOCOMM SOLUTIONS, INC.
445 apollo beach blvd.
apollo beach,  FL  33572
Original Contact jonathan ward
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DSH  
Date Received08/29/2012
Decision Date 02/11/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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