FDA 510(k)

Signus Tetris™ St; Signus Tetris™ R St

K 號：K241438 · 2024-09-11

決定日期2024-09-11

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Signus Tetris™ St; Signus Tetris™ R St is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K241438. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Signus Tetris™ St; Signus Tetris™ R St?

Signus Tetris™ St; Signus Tetris™ R St is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K241438.

When did Signus Tetris™ St; Signus Tetris™ R St receive FDA 510(k) clearance?

Signus Tetris™ St; Signus Tetris™ R St received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241438.

Who is the listed applicant for Signus Tetris™ St; Signus Tetris™ R St?

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

What is the FDA product code for Signus Tetris™ St; Signus Tetris™ R St?

The FDA product code for Signus Tetris™ St; Signus Tetris™ R St is MAX.

其他以 Signus Medizintechnik GmbH 為申請人之記錄

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相關器械（代碼：MAX）

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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