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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 K150512
Device Name STAR 90
Applicant
Skanray Technologies Pvt, Ltd.
# 15-17 Hebbal Industrial Area
Mysore,  IN 570016
Applicant Contact Hema ` Singh
Correspondent
Smith Assoicates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/27/2015
Decision Date 06/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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