FDA 510(k)

EMM 超聲波傳感器蓋

K 號：K211969 · 2021-08-13

決定日期2021-08-13

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

EMM Ultrasonic Transducer Cover is the device name listed in this FDA 510(k) record. The listed applicant is Exact Medical Manufacturing. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211969. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EMM Ultrasonic Transducer Cover?

EMM Ultrasonic Transducer Cover is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Exact Medical Manufacturing. The 510(k) number is K211969.

When did EMM Ultrasonic Transducer Cover receive FDA 510(k) clearance?

EMM Ultrasonic Transducer Cover received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211969.

Who is the listed applicant for EMM Ultrasonic Transducer Cover?

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

What is the FDA product code for EMM Ultrasonic Transducer Cover?

The FDA product code for EMM Ultrasonic Transducer Cover is ITX.

其他以 Exact Medical Manufacturing 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。

K222460手術中超音波探頭蓋

相關器械（代碼：ITX）

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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