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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
Predetermined Change
Control Plan Authorized		 No
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