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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
Model 8001-00140
Device Name CPRMETER CPR FEEDBACK DEVICE
Original Applicant
LAERDAL MEDICAL A/S
1 geddes way
west lafayette,  IN  47906
Original Contact dan dillion
Regulation Number870.5200
Classification Product Code
LIX  
Date Received07/12/2012
Decision Date 10/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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