FDA 510(k)

肺動因振動網狀霧化器

K 號：K202171 · 2021-07-01

決定日期2021-07-01

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Pulmogine Vibrating Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K202171. 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 Pulmogine Vibrating Mesh Nebulizer?

Pulmogine Vibrating Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is Hcmed Innovations Co., Ltd.. The 510(k) number is K202171.

When did Pulmogine Vibrating Mesh Nebulizer receive FDA 510(k) clearance?

Pulmogine Vibrating Mesh Nebulizer received FDA 510(k) clearance on 2021-07-01, under 510(k) number K202171.

Who is the listed applicant for Pulmogine Vibrating Mesh Nebulizer?

The FDA 510(k) record lists Hcmed Innovations Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulmogine Vibrating Mesh Nebulizer?

The FDA product code for Pulmogine Vibrating Mesh Nebulizer is CAF.

其他以 Hcmed Innovations Co., 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。

K250583AdheResp Smart Breath-actuated Mesh Nebulizer

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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