FDA 510(k)

MOBILETT 艾拉麥克斯

K 號：K182639 · 2019-03-15

決定日期2019-03-15

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

MOBILETT Elara Max is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K182639. 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 MOBILETT Elara Max?

MOBILETT Elara Max is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K182639.

When did MOBILETT Elara Max receive FDA 510(k) clearance?

MOBILETT Elara Max received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182639.

Who is the listed applicant for MOBILETT Elara Max?

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

What is the FDA product code for MOBILETT Elara Max?

The FDA product code for MOBILETT Elara Max is IZL.

其他以 Siemens Medi Cal Solutions, Inc. 為申請人之記錄

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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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