FDA 510(k)

mOm Essential Incubator (ME1)

K-Number: K243437 · 2025-08-14

Decision Date2025-08-14

Product CodeFMZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

mOm Essential Incubator (ME1) is a medical device manufactured by Mom Incubators Limited. It received FDA 510(k) clearance on 2025-08-14 under approval number K243437. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mOm Essential Incubator (ME1)?

mOm Essential Incubator (ME1) is a medical device that received FDA 510(k) clearance on 2025-08-14. It is manufactured by Mom Incubators Limited. The 510(k) number is K243437.

When was mOm Essential Incubator (ME1) approved by the FDA?

mOm Essential Incubator (ME1) received FDA 510(k) clearance on 2025-08-14, under approval number K243437.

What company makes mOm Essential Incubator (ME1)?

mOm Essential Incubator (ME1) is manufactured by Mom Incubators Limited.

What is the FDA product code for mOm Essential Incubator (ME1)?

The FDA product code for mOm Essential Incubator (ME1) is FMZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.