FDA 510(k)

Pitch-Patchs

K 號：K211563 · 2021-08-13

決定日期2021-08-13

產品代碼FTL

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

Pitch-Patchs is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211563. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pitch-Patchs?

Pitch-Patchs is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Xiros, Ltd.. The 510(k) number is K211563.

When did Pitch-Patchs receive FDA 510(k) clearance?

Pitch-Patchs received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211563.

Who is the listed applicant for Pitch-Patchs?

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

What is the FDA product code for Pitch-Patchs?

The FDA product code for Pitch-Patchs is FTL.

其他以 Xiros, Ltd. 為申請人之記錄

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相關器械（代碼：FTL）

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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