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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K102433
Device Name MOORVMS-PRES PRESSURE CUFF CONTROLLER
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 Number870.2100
Classification Product Code
DPW  
Date Received08/26/2010
Decision Date 11/18/2010
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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