FDA 510(k)

Fetal & Maternal Monitor (F15A, F15A Air)

Número K: K241882 · 2025-08-27

Data da decisão2025-08-27

Código do produtoHGM

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fetal & Maternal Monitor (F15A, F15A Air) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K241882. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fetal & Maternal Monitor (F15A, F15A Air)?

Fetal & Maternal Monitor (F15A, F15A Air) is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K241882.

When did Fetal & Maternal Monitor (F15A, F15A Air) receive FDA 510(k) clearance?

Fetal & Maternal Monitor (F15A, F15A Air) received FDA 510(k) clearance on 2025-08-27, under 510(k) number K241882.

Who is the listed applicant for Fetal & Maternal Monitor (F15A, F15A Air)?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal & Maternal Monitor (F15A, F15A Air)?

The FDA product code for Fetal & Maternal Monitor (F15A, F15A Air) is HGM.

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Fonte oficial

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