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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K893861
Device Name TMI LW-100 PULSED DOPPLER SYSTEM
Applicant
Titronics Medical Instruments, Inc.
P.O. Box 2202
Iowa City,  IA  52244
Applicant Contact PATRICK EDWARDS
Correspondent
Titronics Medical Instruments, Inc.
P.O. Box 2202
Iowa City,  IA  52244
Correspondent Contact PATRICK EDWARDS
Regulation Number892.1550
Classification Product Code
IYN  
Date Received05/25/1989
Decision Date 02/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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