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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K060976
Device Name MOORLD12-B1 LASER DOPPLER BURNS IMAGER
Applicant
Moor Instruments, Ltd.
Millwey
Axminster, Devon,  GB EX13 5HU
Applicant Contact DAVID BOGGETT
Correspondent
Moor Instruments, Ltd.
Millwey
Axminster, Devon,  GB EX13 5HU
Correspondent Contact DAVID BOGGETT
Regulation Number870.2120
Classification Product Code
DPT  
Subsequent Product Code
GEX  
Date Received04/10/2006
Decision Date 03/27/2007
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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