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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 K823081
Device Name M2100 ANTEPARTUM FETAL MONITOR
Applicant
HUNTLEIGH TECHNOLOGY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HUNTLEIGH TECHNOLOGY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.2740
Classification Product Code
HGM  
Date Received10/19/1982
Decision Date 01/26/1983
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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