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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 K122050
Device Name CPRMETER CPR FEEDBACK DEVICE
Applicant
LAERDAL MEDICAL A/S
1 Geddes Way
West Lafayette,  IN  47906
Applicant Contact DAN DILLION
Correspondent
LAERDAL MEDICAL A/S
1 Geddes Way
West Lafayette,  IN  47906
Correspondent Contact DAN DILLION
Regulation Number870.5210
Classification Product Code
LIX  
Date Received07/12/2012
Decision Date 10/22/2012
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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