FDA 510(k)

Imaging Plate Scanner, i-Scan

Número K: K212080 · 2021-09-27

RequerenteGuilin Woodpecker Medical Instrument Co., Ltd.

Data da decisão2021-09-27

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Imaging Plate Scanner, i-Scan is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K212080. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Imaging Plate Scanner, i-Scan?

Imaging Plate Scanner, i-Scan is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K212080.

When did Imaging Plate Scanner, i-Scan receive FDA 510(k) clearance?

Imaging Plate Scanner, i-Scan received FDA 510(k) clearance on 2021-09-27, under 510(k) number K212080.

Who is the listed applicant for Imaging Plate Scanner, i-Scan?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Imaging Plate Scanner, i-Scan?

The FDA product code for Imaging Plate Scanner, i-Scan is MUH.

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Fonte oficial

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