FDA 510(k)

Vatech Clismile

K号: K220689 · 2022-05-06

决定日期2022-05-06

产品代码NJM

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决定实质等同

器械摘要

Vatech Clismile is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K220689. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vatech Clismile?

Vatech Clismile is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K220689.

When did Vatech Clismile receive FDA 510(k) clearance?

Vatech Clismile received FDA 510(k) clearance on 2022-05-06, under 510(k) number K220689.

Who is the listed applicant for Vatech Clismile?

FDA 510(k)记录将Rayence Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Vatech Clismile?

The FDA product code for Vatech Clismile is NJM.

列明Rayence 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。

K2538000909FCE，0909FCE-HS K2438492430TCA with Xmaru W K242394数字平板X射线探测器（1717WCE，1717WCE-HR，1717WCE-HS，1717WCE-GF）K2403710909FCC, 0909FCC-HS K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF K2127530909FCB, 1212FCA

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官方来源

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