FDA 510(k)

CO2 Laser Machine, Model: BW-203B

K-Number: K211735 · 2021-10-22

ApplicantZhengzhou Bestview ST Co., Ltd.

Decision Date2021-10-22

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CO2 Laser Machine, Model: BW-203B is a medical device manufactured by Zhengzhou Bestview ST Co., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under approval number K211735. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 Laser Machine, Model: BW-203B?

CO2 Laser Machine, Model: BW-203B is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Zhengzhou Bestview ST Co., Ltd.. The 510(k) number is K211735.

When was CO2 Laser Machine, Model: BW-203B approved by the FDA?

CO2 Laser Machine, Model: BW-203B received FDA 510(k) clearance on 2021-10-22, under approval number K211735.

What company makes CO2 Laser Machine, Model: BW-203B?

CO2 Laser Machine, Model: BW-203B is manufactured by Zhengzhou Bestview ST Co., Ltd..

What is the FDA product code for CO2 Laser Machine, Model: BW-203B?

The FDA product code for CO2 Laser Machine, Model: BW-203B is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.