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FDA 510(k)

福利氏導尿管配溫度感測器

K 號:K200757 · 2020-10-15

決定日期2020-10-15
產品代碼EYC
諮詢委員會GU
決定相當於

器材摘要

Foley Catheter with Temperature Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-10-15 under 510(k) number K200757. The device is classified under product code EYC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Foley Catheter with Temperature Sensor?

Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K200757.

When did Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2020-10-15, under 510(k) number K200757.

Who is the listed applicant for Foley Catheter with Temperature Sensor?

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

What is the FDA product code for Foley Catheter with Temperature Sensor?

The FDA product code for Foley Catheter with Temperature Sensor is EYC.

相關臨床試驗

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其他以 Deroyal Industries, 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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