FDA 510(k)

CMDR 2C（多款型號）

K 號：K201575 · 2020-07-08

決定日期2020-07-08

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

CMDR 2C (Multiple Models) is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2020-07-08 under 510(k) number K201575. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CMDR 2C (Multiple Models)?

CMDR 2C (Multiple Models) is a medical device that received FDA 510(k) clearance on 2020-07-08. The listed applicant is Minxray, Inc.. The 510(k) number is K201575.

When did CMDR 2C (Multiple Models) receive FDA 510(k) clearance?

CMDR 2C (Multiple Models) received FDA 510(k) clearance on 2020-07-08, under 510(k) number K201575.

Who is the listed applicant for CMDR 2C (Multiple Models)?

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

What is the FDA product code for CMDR 2C (Multiple Models)?

The FDA product code for CMDR 2C (Multiple Models) is IZL.

其他以 Minxray, 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：IZL）

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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