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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K243437
Device Name mOm Essential Incubator (ME1)
Applicant
Mom Incubators Limited
Newstead House
Pelham Rd.
Nottingham,  GB NG5 1AP
Applicant Contact Rosalyn Archer
Correspondent
Mom Incubators Limited
Newstead House
Pelham Rd.
Nottingham,  GB NG5 1AP
Correspondent Contact Rosalyn Archer
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received11/05/2024
Decision Date 08/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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