FDA 510(k)

ENDOSCOPE REPROCESSOR OER-Elite

Número K: K190969 · 2019-07-09

Data da decisão2019-07-09

Código do produtoFEB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ENDOSCOPE REPROCESSOR OER-Elite is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-07-09 under 510(k) number K190969. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ENDOSCOPE REPROCESSOR OER-Elite?

ENDOSCOPE REPROCESSOR OER-Elite is a medical device that received FDA 510(k) clearance on 2019-07-09. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K190969.

When did ENDOSCOPE REPROCESSOR OER-Elite receive FDA 510(k) clearance?

ENDOSCOPE REPROCESSOR OER-Elite received FDA 510(k) clearance on 2019-07-09, under 510(k) number K190969.

Who is the listed applicant for ENDOSCOPE REPROCESSOR OER-Elite?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPE REPROCESSOR OER-Elite?

The FDA product code for ENDOSCOPE REPROCESSOR OER-Elite is FEB.

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Outros registros que listam Olympus Medical Systems Corp. como candidato(a)

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Fonte oficial

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