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510(k) K243437

mOm Essential Incubator (ME1) by Mom Incubators Limited — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2025
Date Received
November 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

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