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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Embryo Image Assessment System, Assisted Reproduction
510(k) Number K243851
Device Name CHLOE BLAST
Applicant
Fairtility , Ltd.
8 Ha’Melacha St.
Tel-Aviv,  IL 6721508
Applicant Contact Maya Baranes Zeevi
Correspondent
Sfadc, LLC
2425 L St., NW
Apt. 307
Washington,  DC  20037
Correspondent Contact Susan Alpert
Regulation Number884.6195
Classification Product Code
PBH  
Date Received12/16/2024
Decision Date 08/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT05455281
NCT06111365
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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