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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 K922034
Device Name LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER
Applicant
Titronics Medical Instruments, Inc.
P.O. Box 2202
Iowa City,  IA  52244
Applicant Contact CLAUDIA CARVER
Correspondent
Titronics Medical Instruments, Inc.
P.O. Box 2202
Iowa City,  IA  52244
Correspondent Contact CLAUDIA CARVER
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/01/1992
Decision Date 05/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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