FDA 510(k)

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

K 號：K173639 · 2018-04-02

決定日期2018-04-02

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax 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 2018-04-02 under 510(k) number K173639. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K173639.

When did Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax receive FDA 510(k) clearance?

Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax received FDA 510(k) clearance on 2018-04-02, under 510(k) number K173639.

Who is the listed applicant for Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

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 Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax?

The FDA product code for Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax is OWB.

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：OWB）

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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