FDA 510(k)

Butterfly Gestational Age Tool

Número K: K252148 · 2026-03-27

Data da decisão2026-03-27

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Butterfly Gestational Age Tool is the device name listed in this FDA 510(k) record. The listed applicant is Butterfly Network, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K252148. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Butterfly Gestational Age Tool?

Butterfly Gestational Age Tool is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K252148.

When did Butterfly Gestational Age Tool receive FDA 510(k) clearance?

Butterfly Gestational Age Tool received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252148.

Who is the listed applicant for Butterfly Gestational Age Tool?

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

What is the FDA product code for Butterfly Gestational Age Tool?

The FDA product code for Butterfly Gestational Age Tool is IYN.

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