FDA 510(k)

Esteya

K 號：K213942 · 2022-01-11

決定日期2022-01-11

產品代碼JAD

諮詢委員會RA

決定相當於

器材摘要

Esteya is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213942. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Esteya?

Esteya is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Nucletron B.V.. The 510(k) number is K213942.

When did Esteya receive FDA 510(k) clearance?

Esteya received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213942.

Who is the listed applicant for Esteya?

FDA 510(k) 記錄將 Nucletron B.V. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Esteya?

The FDA product code for Esteya is JAD.

其他以 Nucletron B.V. 為申請人之記錄

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官方來源

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