FDA 510(k)

維洛克斯霧化系統

K 號：K162785 · 2017-04-14

決定日期2017-04-14

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Velox Nebulizer System is the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K162785. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Velox Nebulizer System?

Velox Nebulizer System is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K162785.

When did Velox Nebulizer System receive FDA 510(k) clearance?

Velox Nebulizer System received FDA 510(k) clearance on 2017-04-14, under 510(k) number K162785.

Who is the listed applicant for Velox Nebulizer System?

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

What is the FDA product code for Velox Nebulizer System?

The FDA product code for Velox Nebulizer System is CAF.

其他以 Pari Respiratory Equipment, Inc. 為申請人之記錄

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K251572eRapid 配合 eTrack 系統 K223840eRapid噴霧器系統 K191270Proneb Max K150044O-PEP

相關器械（代碼：CAF）

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。

K254171網狀噴霧器（UN204）；網狀噴霧器（UN205）；網狀噴霧器（UN209）；網狀噴霧器（UN210）Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE 用於噴劑吸入器 (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid 配合 eTrack 系統Pari Respiratory Equipment, Inc.K251659網狀霧化器（H6）Qingdao Future Medical Technology Co., Ltd.K244035攜帶式網狀霧化器（JM821）Shenzhen Jermei Medical Device Technology Co., Ltd.K243468壓縮式霧化器（NB-1100）；壓縮式霧化器（NB-1101）；壓縮式霧化器（NB-1102）；壓縮式霧化器（NB-1103）Joytech Healthcare Co. , Ltd.

官方來源

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