FDA 510(k)

R-Sensor, R-Sensor

K 號：K200284 · 2020-02-28

決定日期2020-02-28

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

R-Sensor, R-Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Remedi Co., Ltd.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K200284. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the R-Sensor, R-Sensor?

R-Sensor, R-Sensor is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Remedi Co., Ltd.. The 510(k) number is K200284.

When did R-Sensor, R-Sensor receive FDA 510(k) clearance?

R-Sensor, R-Sensor received FDA 510(k) clearance on 2020-02-28, under 510(k) number K200284.

Who is the listed applicant for R-Sensor, R-Sensor?

The FDA 510(k) record lists Remedi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R-Sensor, R-Sensor?

The FDA product code for R-Sensor, R-Sensor is MUH.

其他以 Remedi Co., Ltd. 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：MUH）

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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