FDA 510(k)

UreTron PF系列探針

K 號：K162119 · 2016-08-29

決定日期2016-08-29

產品代碼FFK

諮詢委員會GU

決定相當於

器材摘要

UreTron PF Series Probe is the device name listed in this FDA 510(k) record. The listed applicant is Med-Sonics Corp.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K162119. 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 UreTron PF Series Probe?

UreTron PF Series Probe is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Med-Sonics Corp.. The 510(k) number is K162119.

When did UreTron PF Series Probe receive FDA 510(k) clearance?

UreTron PF Series Probe received FDA 510(k) clearance on 2016-08-29, under 510(k) number K162119.

Who is the listed applicant for UreTron PF Series Probe?

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

What is the FDA product code for UreTron PF Series Probe?

The FDA product code for UreTron PF Series Probe is FFK.

其他以 Med-Sonics 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。

K160198UreTron 多探針碎石系統

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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