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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 K253021
Device Name ANNE Maternal
Applicant
Sibel Health, Inc.
2017 N Mendell St.
Chicago,  IL  60614
Applicant Contact Kevin Dwyer
Correspondent
Sibel Health, Inc.
2017 N Mendell St.
Chicago,  IL  60614
Correspondent Contact Kevin Dwyer
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Codes
DRG   DSJ   KMI   MSW   MSX  
Date Received09/19/2025
Decision Date 02/26/2026
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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