FDA 510(k)

圧縮式霧化器（NB-1100）；圧縮式霧化器（NB-1101）；圧縮式霧化器（NB-1102）；圧縮式霧化器（NB-1103）

K番号: K243468 · 2025-07-02

決定日2025-07-02

製品コードCAF

諮問委員会AN 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細情報や製品の詳細については、以下のURLをご参照ください。 [URL]

決定Substantially Equivalent

医療機器の概要

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K243468. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)?

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K243468.

When did Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) receive FDA 510(k) clearance?

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K243468.

Who is the listed applicant for Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)?

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

What is the FDA product code for Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)?

The FDA product code for Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) is CAF.

申請者としてJoytech Healthcare Co. , Ltd.を記載するその他の記録

K261394腕型全自動デジタル血圧計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）K253425腕型全自動デジタル血圧計（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）K252501上腕型全自動デジタル血圧計（DBP-62E3B、DBP-62E2B、DBP-62E1B、DBP-61E3、DBP-61E2、DBP-61E1、DBP-61D7G、DBP-6281L、DBP-6282L、DBP-6285L）K252685上腕型完全自動デジタル血圧計（DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P）K250548上腕型全自動デジタル血圧計（DBP-6286B、DBP-6186）K241431上腕型全自動デジタル血圧計（DBP-62D0L、DBP-62D0B、DBP-61D0、DBP-61D0L、DBP-6293L、DBP-6293B、DBP-6193）

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