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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 echo, ultrasonic
510(k) Number K896150
Device Name IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC
Original Applicant
TEKNAR, INC.
267 wolfner dr.
fenton,  MO  63026 -2801
Original Contact kenneth o head
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/23/1989
Decision Date 01/18/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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