FDA 510(k)

Advanced 妇科應用器

K 號：K161688 · 2017-01-27

決定日期2017-01-27

產品代碼JAQ

諮詢委員會RA

決定相當於

器材摘要

Advanced Gynecological Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron B.V.. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K161688. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advanced Gynecological Applicator?

Advanced Gynecological Applicator is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Nucletron B.V.. The 510(k) number is K161688.

When did Advanced Gynecological Applicator receive FDA 510(k) clearance?

Advanced Gynecological Applicator received FDA 510(k) clearance on 2017-01-27, under 510(k) number K161688.

Who is the listed applicant for Advanced Gynecological Applicator?

FDA 510(k) 記錄將 Nucletron B.V. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Advanced Gynecological Applicator?

The FDA product code for Advanced Gynecological Applicator is JAQ.

其他以 Nucletron B.V. 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。

K262383LumenCare 銀河 K251037直腸施藥器 K213942Esteya K201272基納瓦

相關器械（代碼：JAQ）

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。

K262383LumenCare 銀河Nucletron B.V.K252717MAASTRO 直腸施藥器組Varian Medical Systems K251037直腸施藥器Nucletron B.V.K252884導向阿魯斯應用器組Varian Medical Systems K250299CT/ MR 串聯及卵形組合Varian Medical Systems, Inc.K250289內腔/間質系統Varian Medical Systems

官方來源

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