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FDA 510(k)

mOm Essential Incubator (ME1)

K-Number: K243437 · 2025-08-14

ApplicantMom Incubators Limited
Decision Date2025-08-14
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

mOm Essential Incubator (ME1) is the device name listed in this FDA 510(k) record. The listed applicant is Mom Incubators Limited. It received FDA 510(k) clearance on 2025-08-14 under 510(k) 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. The listed applicant is Mom Incubators Limited. The 510(k) number is K243437.

When did mOm Essential Incubator (ME1) receive FDA 510(k) clearance?

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

Who is the listed applicant for mOm Essential Incubator (ME1)?

The FDA 510(k) record lists Mom Incubators Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: FMZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.K182859Babyleo TN500Dragerwerk AG & CO Kgaa

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.

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