FDA 510(k)

mOm Essential Incubator (ME1)

N.º K: K243437 · 2025-08-14

Fecha de decisión2025-08-14

Código de productoFMZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: FMZ)

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Fuente oficial

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