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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, obstetric
510(k) Number K903348
Device Name ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
Applicant
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Applicant Contact TERRENCE J SWEENEY
Correspondent
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Correspondent Contact TERRENCE J SWEENEY
Regulation Number884.2960
Classification Product Code
HGL  
Date Received07/26/1990
Decision Date 10/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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