FDA 510(k)

D-Laser Blue，D-Laser 16

K号: K210367 · 2022-03-10

申请人Guilin Woodpecker Medical Instrument Co., Ltd.

决定日期2022-03-10

产品代码NVK

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决定实质等同

器械摘要

D-Laser Blue, D-Laser 16 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 2022-03-10 under 510(k) number K210367. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the D-Laser Blue, D-Laser 16?

D-Laser Blue, D-Laser 16 is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K210367.

When did D-Laser Blue, D-Laser 16 receive FDA 510(k) clearance?

D-Laser Blue, D-Laser 16 received FDA 510(k) clearance on 2022-03-10, under 510(k) number K210367.

Who is the listed applicant for D-Laser Blue, D-Laser 16?

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 D-Laser Blue, D-Laser 16?

The FDA product code for D-Laser Blue, D-Laser 16 is NVK.