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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 K241882
Device Name Fetal & Maternal Monitor (F15A, F15A Air)
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan Distrct
Shenzhen,  CN 518122
Applicant Contact Yue Tracy
Correspondent
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan Distrct
Shenzhen,  CN 518122
Correspondent Contact Yue Tracy
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
DPS   DQA   DRT   DSJ   DSK  
DXN   FLL   HFM   HFN   HGL  
Date Received06/28/2024
Decision Date 08/27/2025
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
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