FDA 510(k)

!M1

K 號：K170607 · 2017-07-17

決定日期2017-07-17

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

!M1 is the device name listed in this FDA 510(k) record. The listed applicant is Solutions For Tomorrow AB. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K170607. 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 !M1?

!M1 is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Solutions For Tomorrow AB. The 510(k) number is K170607.

When did !M1 receive FDA 510(k) clearance?

!M1 received FDA 510(k) clearance on 2017-07-17, under 510(k) number K170607.

Who is the listed applicant for !M1?

The FDA 510(k) record lists Solutions For Tomorrow AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for !M1?

The FDA product code for !M1 is IZL.

其他以 Solutions For Tomorrow AB 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。

K251710移動X光單位 (!M1)K241980!M1

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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官方來源

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