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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 K142352
Device Name CardiacLinx
Applicant
Ross Medical Technology, Inc
82 E. ALLENDALE ROAD, SUITE 8A
saddle river,  NJ  07458
Applicant Contact alexander chiu
Correspondent
Ross Medical Technology, Inc
82 E. ALLENDALE ROAD, SUITE 8A
saddle river,  NJ  07458
Correspondent Contact alexander chiu
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DPS   DQK  
Date Received08/22/2014
Decision Date 03/12/2015
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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