攜帶式網狀霧化器（JM821）
K 號：K244035 · 2025-09-19
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器材摘要
Portable mesh nebulizer (JM821) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K244035. 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 Portable mesh nebulizer (JM821)?
Portable mesh nebulizer (JM821) is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Shenzhen Jermei Medical Device Technology Co., Ltd.. The 510(k) number is K244035.
When did Portable mesh nebulizer (JM821) receive FDA 510(k) clearance?
Portable mesh nebulizer (JM821) received FDA 510(k) clearance on 2025-09-19, under 510(k) number K244035.
Who is the listed applicant for Portable mesh nebulizer (JM821)?
The FDA 510(k) record lists Shenzhen Jermei Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portable mesh nebulizer (JM821)?
The FDA product code for Portable mesh nebulizer (JM821) is CAF.
相關臨床試驗
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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。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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