FDA 510(k)

mOm Essential Incubator (ME1)

Номер K: K243437 · 2025-08-14

Дата решения2025-08-14

Код продуктаFMZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FMZ)

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaA K251663Giraffe 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

Официальный источник

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