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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 K132163
Device Name MOORLDLS-BI LASER DOPPLER BURNS IMAGER
Applicant
Moor Instruments, Ltd.
Millwey
Axminster, Devon,  GB EX13 5HU
Applicant Contact XIABING HUANG
Correspondent
Moor Instruments, Ltd.
Millwey
Axminster, Devon,  GB EX13 5HU
Correspondent Contact XIABING HUANG
Regulation Number870.2120
Classification Product Code
DPT  
Subsequent Product Code
GEX  
Date Received07/12/2013
Decision Date 01/29/2014
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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