FDA 510(k)

EVOCLEAN 清潔針超聲波植入器

K 號：K210832 · 2022-02-02

決定日期2022-02-02

產品代碼ELC

諮詢委員會DE

決定相當於

器材摘要

EVOCLEAN CLEANsert Ultrasonic Insert is the device name listed in this FDA 510(k) record. The listed applicant is Ttbio Corp.. It received FDA 510(k) clearance on 2022-02-02 under 510(k) number K210832. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EVOCLEAN CLEANsert Ultrasonic Insert?

EVOCLEAN CLEANsert Ultrasonic Insert is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Ttbio Corp.. The 510(k) number is K210832.

When did EVOCLEAN CLEANsert Ultrasonic Insert receive FDA 510(k) clearance?

EVOCLEAN CLEANsert Ultrasonic Insert received FDA 510(k) clearance on 2022-02-02, under 510(k) number K210832.

Who is the listed applicant for EVOCLEAN CLEANsert Ultrasonic Insert?

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

What is the FDA product code for EVOCLEAN CLEANsert Ultrasonic Insert?

The FDA product code for EVOCLEAN CLEANsert Ultrasonic Insert is ELC.

其他以 Ttbio Corp. 為申請人之記錄

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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相關器械（代碼：ELC）

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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