FDA 510(k)

Atellica CH 鎂 (Mg)

K 號：K162399 · 2017-01-19

決定日期2017-01-19

產品代碼JGJ

諮詢委員會CH

決定相當於

器材摘要

Atellica CH Magnesium (Mg) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K162399. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Atellica CH Magnesium (Mg)?

Atellica CH Magnesium (Mg) is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K162399.

When did Atellica CH Magnesium (Mg) receive FDA 510(k) clearance?

Atellica CH Magnesium (Mg) received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162399.

Who is the listed applicant for Atellica CH Magnesium (Mg)?

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Atellica CH Magnesium (Mg)?

The FDA product code for Atellica CH Magnesium (Mg) is JGJ.

其他以 Siemens Healthcare Diagnostics, 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：JGJ）

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。

K181748鎂Abbott Laboratories K173294鎂Abbott Laboratories K162200Randox RX Daytona Plus 镁 (MG)Randox Laboratories, Ltd.

官方來源

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