FDA 510(k)

HP-OCT (HP-OCT)

Número K: K231760 · 2024-03-08

Data da decisão2024-03-08

Código do produtoHJO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

HP-OCT (HP-OCT) is the device name listed in this FDA 510(k) record. The listed applicant is Cylite Pty. , Ltd.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K231760. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HP-OCT (HP-OCT)?

HP-OCT (HP-OCT) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Cylite Pty. , Ltd.. The 510(k) number is K231760.

When did HP-OCT (HP-OCT) receive FDA 510(k) clearance?

HP-OCT (HP-OCT) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231760.

Who is the listed applicant for HP-OCT (HP-OCT)?

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

What is the FDA product code for HP-OCT (HP-OCT)?

The FDA product code for HP-OCT (HP-OCT) is HJO.

Outros registros que listam Cylite Pty. , Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K252633UNITY DX (UDX)

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Fonte oficial

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