FDA 510(k)

源生製造設備有限公司模型 M14 192Iridium 近端放射源

K 號：K162573 · 2016-11-04

申請人Source Production and Equipment Co., Inc.

決定日期2016-11-04

產品代碼KXK

諮詢委員會RA

決定相當於

器材摘要

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162573. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Source Production and Equipment Co., Inc.. The 510(k) number is K162573.

When did Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source receive FDA 510(k) clearance?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162573.

Who is the listed applicant for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA 510(k) record lists Source Production and Equipment Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is KXK.

其他以 Source Production and Equipment Co., Inc. 為申請人之記錄

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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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