FDA 510(k)

VT - 100, VT - 200

K 號：K173407 · 2018-08-09

決定日期2018-08-09

產品代碼OMP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VT - 100, VT - 200 is the device name listed in this FDA 510(k) record. The listed applicant is Carilex Medical, Inc.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K173407. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VT - 100, VT - 200?

VT - 100, VT - 200 is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Carilex Medical, Inc.. The 510(k) number is K173407.

When did VT - 100, VT - 200 receive FDA 510(k) clearance?

VT - 100, VT - 200 received FDA 510(k) clearance on 2018-08-09, under 510(k) number K173407.

Who is the listed applicant for VT - 100, VT - 200?

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

What is the FDA product code for VT - 100, VT - 200?

The FDA product code for VT - 100, VT - 200 is OMP.

其他以 Carilex Medical, 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。

K231646Carilex VT¿200-i NX K172725VT 製藥包 K161410VT·One, VT·One 60天

相關器械（代碼：OMP）

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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