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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K152905
Device Name ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
Applicant
Arc Devices Limited
2 Deerpark Industrial Estate, Oranmore
Galway,  IE H91 D72H
Applicant Contact GARY BROGAN
Correspondent
Arc Devices Limited
2 Deerpark Industrial Estate, Oranmore
Galway,  IE H91 D72H
Correspondent Contact GARY BROGAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/01/2015
Decision Date 07/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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