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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 K063561
Device Name MOORLDLS LASER DOPPLER LINE SCANNER
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  
Date Received11/27/2006
Decision Date 01/19/2007
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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