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FDA 510(k)

Pollogen STOP U 型 UXV 裝置

K 號:K220322 · 2023-05-04

決定日期2023-05-04
產品代碼PAY
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

Pollogen STOP U Model UXV Device is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K220322. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pollogen STOP U Model UXV Device?

Pollogen STOP U Model UXV Device is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Pollogen, Ltd.. The 510(k) number is K220322.

When did Pollogen STOP U Model UXV Device receive FDA 510(k) clearance?

Pollogen STOP U Model UXV Device received FDA 510(k) clearance on 2023-05-04, under 510(k) number K220322.

Who is the listed applicant for Pollogen STOP U Model UXV Device?

The FDA 510(k) record lists Pollogen, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pollogen STOP U Model UXV Device?

The FDA product code for Pollogen STOP U Model UXV Device is PAY.

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其他以 Pollogen, Ltd. 為申請人之記錄

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相關器械(代碼:PAY)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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