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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 K222327
Device Name Bloomlife MFM-Pro
Applicant
Bloom Technologies NV
Schiepse Bos 6
Genk,  BE 3600
Applicant Contact Roberto Cunha
Correspondent
Bloomlife, Inc.
181 2nd St.
San Francisco,  CA  94105
Correspondent Contact Roberto Cunha
Regulation Number884.2740
Classification Product Code
HGM  
Date Received08/02/2022
Decision Date 02/13/2023
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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