FDA 510(k)

Seer Home

Número K: K212788 · 2022-06-16

Data da decisão2022-06-16

Código do produtoGWQ

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Seer Home is the device name listed in this FDA 510(k) record. The listed applicant is Seer Medical Pty, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K212788. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Seer Home?

Seer Home is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Seer Medical Pty, Ltd.. The 510(k) number is K212788.

When did Seer Home receive FDA 510(k) clearance?

Seer Home received FDA 510(k) clearance on 2022-06-16, under 510(k) number K212788.

Who is the listed applicant for Seer Home?

The FDA 510(k) record lists Seer Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Seer Home?

The FDA product code for Seer Home is GWQ.

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Fonte oficial

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