FDA 510(k)

Endoscope Reprocessor OER-Elite

N.º K: K201920 · 2020-09-01

SolicitanteOlympus Medical Systems Corp.

Fecha de decisión2020-09-01

Código de productoFEB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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 2020-09-01 under 510(k) number K201920. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Endoscope Reprocessor OER-Elite?

Endoscope Reprocessor OER-Elite is a medical device that received FDA 510(k) clearance on 2020-09-01. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K201920.

When did Endoscope Reprocessor OER-Elite receive FDA 510(k) clearance?

Endoscope Reprocessor OER-Elite received FDA 510(k) clearance on 2020-09-01, under 510(k) number K201920.

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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Otros registros que enlistan a Olympus Medical Systems Corp. como solicitante

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Sujeción Actuada en la Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Sujeción Actuada en la Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Sujeción Actuada en la Frente S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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Dispositivos relacionados (Código: FEB)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.