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FDA 510(k)

NAPA LP-15 氣道壓力監測器

K 號：K172284 · 2018-02-09

申請人Drw Medical, LLC
決定日期2018-02-09
產品代碼CAP
諮詢委員會AN
決定相當於

器材摘要

NAPA LP-15 Airway Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Drw Medical, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172284. 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 NAPA LP-15 Airway Pressure Monitor?

NAPA LP-15 Airway Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Drw Medical, LLC. The 510(k) number is K172284.

When did NAPA LP-15 Airway Pressure Monitor receive FDA 510(k) clearance?

NAPA LP-15 Airway Pressure Monitor received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172284.

Who is the listed applicant for NAPA LP-15 Airway Pressure Monitor?

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

What is the FDA product code for NAPA LP-15 Airway Pressure Monitor?

The FDA product code for NAPA LP-15 Airway Pressure Monitor is CAP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS 氣道壓力計Instrumentation Industries, Inc.K153733VORTRAN 血壓計Vortran Medical Technology 1, Inc.

官方來源

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