FDA 510(k)

VORTRAN APM-Plus

K 號：K182292 · 2019-09-18

決定日期2019-09-18

產品代碼CAP

諮詢委員會AN

決定相當於

器材摘要

VORTRAN APM-Plus is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K182292. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VORTRAN APM-Plus?

VORTRAN APM-Plus is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K182292.

When did VORTRAN APM-Plus receive FDA 510(k) clearance?

VORTRAN APM-Plus received FDA 510(k) clearance on 2019-09-18, under 510(k) number K182292.

Who is the listed applicant for VORTRAN APM-Plus?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTRAN APM-Plus?

The FDA product code for VORTRAN APM-Plus is CAP.

其他以 Vortran Medical Technology 1, 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。

K202219VORTRAN GO2VENT 配備 PEEP 阀 K173914VORTRAN 腕帶充氣器（VCI）K162968VORTRAN GO2VENT K153733VORTRAN 血壓計

相關器械（代碼：CAP）

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。

K201666單次使用壓力計Flexicare Medical Limited.K180510NS 120P-TRS 氣道壓力計Instrumentation Industries, Inc.K172284NAPA LP-15 氣道壓力監測器Drw Medical, LLC K153733VORTRAN 血壓計Vortran Medical Technology 1, Inc.

官方來源

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