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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K161325
Device Name CliniCloud Non-contact Thermometer, Model SPL1024
Applicant
STETHOCLOUD PTY. LTD (CLINICLOUD)
LEVEL 5, 141 FLINDERS LANE
MELBOURNE VIC,  AU 3000
Applicant Contact ANDREW LIN
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/12/2016
Decision Date 06/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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