FDA 510(k)

Leltek 超聲影像系統

K 號：K191235 · 2020-02-12

決定日期2020-02-12

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Leltek Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2020-02-12 under 510(k) number K191235. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Leltek Ultrasound Imaging System?

Leltek Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-02-12. The listed applicant is Leltek, Inc.. The 510(k) number is K191235.

When did Leltek Ultrasound Imaging System receive FDA 510(k) clearance?

Leltek Ultrasound Imaging System received FDA 510(k) clearance on 2020-02-12, under 510(k) number K191235.

Who is the listed applicant for Leltek Ultrasound Imaging System?

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

What is the FDA product code for Leltek Ultrasound Imaging System?

The FDA product code for Leltek Ultrasound Imaging System is IYN.

其他以 Leltek, Inc. 為申請人之記錄

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相關器械（代碼：IYN）

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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