FDA 510(k)

PIUR tUS Infinity

K 號：K240036 · 2024-09-20

決定日期2024-09-20

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

PIUR tUS Infinity is the device name listed in this FDA 510(k) record. The listed applicant is Piur Imaging GmbH. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K240036. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PIUR tUS Infinity?

PIUR tUS Infinity is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Piur Imaging GmbH. The 510(k) number is K240036.

When did PIUR tUS Infinity receive FDA 510(k) clearance?

PIUR tUS Infinity received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240036.

Who is the listed applicant for PIUR tUS Infinity?

The FDA 510(k) record lists Piur Imaging GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIUR tUS Infinity?

The FDA product code for PIUR tUS Infinity is QIH.

其他以 Piur Imaging GmbH 為申請人之記錄

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K250484PIUR tUS內部

相關器械（代碼：QIH）

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。

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官方來源

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