FDA 510(k)

成像板扫描仪，i-Scan

K号: K212080 · 2021-09-27

申请人Guilin Woodpecker Medical Instrument Co., Ltd.

决定日期2021-09-27

产品代码MUH

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决定实质等同

器械摘要

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.

常见问题

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.

列明Guilin Woodpecker Medical Instrument Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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