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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K871383
Device Name FETALERT ADR FETAL MONITOR
Applicant
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Applicant Contact JOHN DELLINGER
Correspondent
Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Correspondent Contact JOHN DELLINGER
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/07/1987
Decision Date 06/01/1987
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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