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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 K860766
Device Name MILLAR PULSED DOPPLER VELOCIMETER
Applicant
Millar Instruments, Inc.
P.O. Box 18227
Houston,  TX  77223
Applicant Contact ROBERT D MIERS
Correspondent
Millar Instruments, Inc.
P.O. Box 18227
Houston,  TX  77223
Correspondent Contact ROBERT D MIERS
Regulation Number870.2100
Classification Product Code
DPW  
Date Received03/03/1986
Decision Date 07/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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