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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 K895123
Device Name 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
Applicant
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Applicant Contact STEVEN CHERNOFF
Correspondent
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Correspondent Contact STEVEN CHERNOFF
Regulation Number884.2960
Classification Product Code
HGL  
Date Received08/15/1989
Decision Date 11/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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