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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K182532
Device Name Liba3 System
Applicant
National Cardiac, Inc.
221 W. Crest Street Suite 205
Escondido,  CA  92025
Applicant Contact Scott Mallett
Correspondent
510k Medical, Inc.
1200 Post Oak Trail
Southlake,  TX  76092
Correspondent Contact Don Canal
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
MHX  
Date Received09/14/2018
Decision Date 05/15/2019
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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