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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K011070
Device Name DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
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 Number878.4810
Classification Product Code
GEX  
Date Received04/09/2001
Decision Date 11/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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