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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 K173042
Device Name Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Applicant Contact Alice Yang
Correspondent
Edan Medical
1200 Crossman Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact Alice Yang
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
DPS   DQA   DRT   DSI   DXN  
FLL   HGL  
Date Received09/28/2017
Decision Date 08/30/2018
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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