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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K172147
Device Name STAR 65
Applicant
Skanray Technologies Pvt Ltd
#360, KIADB Industrial Area, Hebbal,
Mysore,  IN 570018
Applicant Contact Mahadevan J
Correspondent
Elexes
6494 Tralee Village Dr
Dublin,  CA  94568
Correspondent Contact Parul Chansoria
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DQA   DRS   DRT   DSF   DSJ   DXG  
DXN   FLL   KRB   MNR   NHO   NHP  
NHQ  
Date Received07/17/2017
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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