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FDA 510(k)

Tasso+

K 號：K221131 · 2022-08-12

申請人Tasso, Inc.
決定日期2022-08-12
產品代碼FMK
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

Tasso+ is the device name listed in this FDA 510(k) record. The listed applicant is Tasso, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K221131. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tasso+?

Tasso+ is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Tasso, Inc.. The 510(k) number is K221131.

When did Tasso+ receive FDA 510(k) clearance?

Tasso+ received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221131.

Who is the listed applicant for Tasso+?

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

What is the FDA product code for Tasso+?

The FDA product code for Tasso+ is FMK.

相關臨床試驗

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相關器械（代碼：FMK）

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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