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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K200849
Device Name Tempus LS - Manual
Applicant
Remote Diagnostic Technologies, Ltd. A Philips Company
Pavilion C2, Ashwood Park, Ashwood Way
Basingstoke,  GB RG23 8BG
Applicant Contact Martin Newman
Correspondent
Nsf Health Sciences, LLC
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Correspondent Contact Meaghan Bailey
Regulation Number870.5300
Classification Product Code
LDD  
Subsequent Product Codes
DPS   DRO   LIX  
Date Received03/31/2020
Decision Date 07/24/2020
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
Recalls CDRH Recalls
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