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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K092408
Device Name RHYTHM OF LIFE, MODEL R0901-05
Applicant
Rapid Response Solutions, LLC
601 W. 20 St.
Hialeah,  FL  33010
Applicant Contact JORGE MILAN
Correspondent
Rapid Response Solutions, LLC
601 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact JORGE MILAN
Regulation Number870.5210
Classification Product Code
LIX  
Date Received08/06/2009
Decision Date 10/14/2009
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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