FDA 510(k)

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor

Número K: K152205 · 2016-05-06

Data da decisão2016-05-06

Código do produtoOBO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K152205. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor?

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K152205.

When did Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor receive FDA 510(k) clearance?

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor received FDA 510(k) clearance on 2016-05-06, under 510(k) number K152205.

Who is the listed applicant for Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor?

The FDA 510(k) record lists Heidelberg Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor?

The FDA product code for Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor is OBO.

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Outros registros que listam Heidelberg Engineering GmbH como candidato(a)

K261019ANTERION K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module K250868SPECTRALIS HRA+OCT and variants K240924Anterion K241163SPECTRALIS with Flex Module K240221SPECTRALIS HRA+OCT and variants

Ver todos os 16 dispositivos →

Dispositivos Relacionados (Código: OBO)

K261019ANTERIONHeidelberg Engineering GmbH K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH K252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH K240924AnterionHeidelberg Engineering GmbH

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