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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K881329
Device Name FETAL DOPPLER FOR ULTRAMARK 4 AND 8
Applicant
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Applicant Contact JOHN DELLINGER
Correspondent
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Correspondent Contact JOHN DELLINGER
Regulation Number884.2225
Classification Product Code
HEM  
Date Received03/30/1988
Decision Date 04/14/1989
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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