FDA 510(k)

URO-TOUCH 9 法國探針

K 號：K202813 · 2021-06-14

決定日期2021-06-14

產品代碼FFK

諮詢委員會GU

決定相當於

器材摘要

URO-TOUCH 9 French Probe is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 2021-06-14 under 510(k) number K202813. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the URO-TOUCH 9 French Probe?

URO-TOUCH 9 French Probe is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K202813.

When did URO-TOUCH 9 French Probe receive FDA 510(k) clearance?

URO-TOUCH 9 French Probe received FDA 510(k) clearance on 2021-06-14, under 510(k) number K202813.

Who is the listed applicant for URO-TOUCH 9 French Probe?

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

What is the FDA product code for URO-TOUCH 9 French Probe?

The FDA product code for URO-TOUCH 9 French Probe is FFK.

其他以 Northgate Technologies, Inc. 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：FFK）

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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