FDA 510(k)

電動乳泵（LD-208L、LD-3010L、LD-2010L、LD-3010、LD-2010）

K 號：K241322 · 2024-12-19

決定日期2024-12-19

產品代碼HGX

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) 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 2024-12-19 under 510(k) number K241322. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K241322.

When did Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) receive FDA 510(k) clearance?

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K241322.

Who is the listed applicant for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?

FDA 510(k) 記錄將 Joytech Healthcare Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)?

The FDA product code for Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) is HGX.

其他以 Joytech Healthcare 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。

K261394臂式全自動數字血壓計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）K253425臂式全自动數字血壓監測儀（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手臂型全自动數字血壓監測儀（DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L）K252685手臂型全自动數字血壓監測儀（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）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）K250548臂式全自动數字血壓監測儀（DBP-6286B，DBP-6186）

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相關器械（代碼：HGX）

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

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