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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 K123248
Device Name CPR RSQ ASSIST
Applicant
Avantech, Inc.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact STEVEN B DATLOF
Correspondent
Avantech, Inc.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact STEVEN B DATLOF
Regulation Number870.5210
Classification Product Code
LIX  
Date Received10/17/2012
Decision Date 12/10/2013
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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