FDA 510(k)

VT·One, VT·One 60天

K 號：K161410 · 2016-10-13

決定日期2016-10-13

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·One, VT·One 60days 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 2016-10-13 under 510(k) number K161410. 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·One, VT·One 60days?

VT·One, VT·One 60days is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Carilex Medical, Inc.. The 510(k) number is K161410.

When did VT·One, VT·One 60days receive FDA 510(k) clearance?

VT·One, VT·One 60days received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161410.

Who is the listed applicant for VT·One, VT·One 60days?

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·One, VT·One 60days?

The FDA product code for VT·One, VT·One 60days 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。

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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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