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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K173553
FOIA Releasable 510(k) K173553
Device Name LUCAS 3 Chest Compression System
Applicant
Jolife AB
Scheelevagen 17
Ideon Science Park
Lund,  SE 22370
Applicant Contact Malin Melander
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number870.5200
Classification Product Code
DRM  
Date Received11/16/2017
Decision Date 02/08/2018
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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