FDA 510(k)

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

Número K: K201983 · 2020-10-09

RequerenteMed-El Elektromedizinische Geraete GmbH

Data da decisão2020-10-09

Código do produtoPFO

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is the device name listed in this FDA 510(k) record. The listed applicant is Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K201983. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)?

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K201983.

When did BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) receive FDA 510(k) clearance?

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) received FDA 510(k) clearance on 2020-10-09, under 510(k) number K201983.

Who is the listed applicant for BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)?

The FDA 510(k) record lists Med-El Elektromedizinische Geraete GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)?

The FDA product code for BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is PFO.

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Outros registros que listam Med-El Elektromedizinische Geraete GmbH como candidato(a)

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Fonte oficial

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