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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K133252
Device Name HEALTHINTERLINK BEACON
Applicant
HEALTHINTERLINK, LLC
55 NORTHERN BLVD, STE. 200
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
HEALTHINTERLINK, LLC
55 NORTHERN BLVD, STE. 200
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   DXN   FLL   FRI   JQP  
NBW  
Date Received10/22/2013
Decision Date 03/14/2014
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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