FDA 510(k)

霧化器

K 號：K212395 · 2022-03-25

申請人Shenzhen Homed Medical Device Co., Ltd.

決定日期2022-03-25

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K212395. 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 Nebulizer?

Nebulizer is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K212395.

When did Nebulizer receive FDA 510(k) clearance?

Nebulizer received FDA 510(k) clearance on 2022-03-25, under 510(k) number K212395.

Who is the listed applicant for Nebulizer?

The FDA 510(k) record lists Shenzhen Homed Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nebulizer?

The FDA product code for Nebulizer is CAF.

其他以 Shenzhen Homed Medical Device 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。

K252616攜帶式氧氣濃縮機（JLO-190P）K170886HOMED 網狀霧化器 K161586JLN-23XX系列活塞壓縮霧化器（含型號JLN-2300AS、JLN-2301AS、JLN-2317AS及JLN-2320AS）

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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