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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 K131941
Device Name FETAL MONITORS
Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
GUANGDONG BIOLIGHT MEDITECH CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/27/2013
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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