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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 K183348
Device Name Reusable Silicone Cover CPRmeter 2
Applicant
Laerdal Medical AS
Tanke Svilandsgate 30
Stavanger,  NO 2007
Applicant Contact Mari Kaada
Correspondent
Med Institute, Inc.
1330 Win Hentschel Blvd.
Lafayette,  IN  47906
Correspondent Contact Dan Dillon
Regulation Number870.5210
Classification Product Code
LIX  
Date Received12/03/2018
Decision Date 12/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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