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FDA 510(k)

Microstream Advance 新生兒-嬰兒鼻用濾過管路連氧氣管，Microstream Advance 小兒口鼻濾過管路連氧氣管，Microstream Advance 成人口鼻濾過管路連氧氣管，Microstream Luer 成人口鼻採樣管

K 號：K181624 · 2019-03-22

申請人Oridion Medical 1987 , Ltd.
決定日期2019-03-22
產品代碼CCK
諮詢委員會AN
決定相當於

器材摘要

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181624. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line?

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K181624.

When did Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line receive FDA 510(k) clearance?

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181624.

Who is the listed applicant for Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line?

The FDA product code for Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line is CCK.

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

其他以 Oridion Medical 1987 , Ltd. 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。

K200594Capnostream 35 輕便呼吸監測器K181467Microstream Luer成人-兒童插管採樣線，Microstream Advance成人-兒童插管過濾線

相關器械（代碼：CCK）

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。

K251641GF-310R 多氣體單元（GF-310R）Nihon Kohden CorporationK261633視覺呼吸Affirm Medical Technologies II, LLCK253030Capnostream™35 輕便呼吸監測器 (PM35MN)Covidien, LLCK250148醫療氣體分析儀（AG200）Prior Care Science Technology, Ltd.K243956TG-980P 二氧化碳感測器套件（TG-980P）；TG-980P1 二氧化碳感測器套件（TG-980P1）Nihon Kohden CorporationK2512160184 CO2 標本採集管；0184T CO2 標本採集管；0139 CO2 標本採集管；0182 CO2 標本採集管Barbaras Development, Inc.

官方來源

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