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FDA 510(k)

胎兒多普勒（型號：FD-231B、FD-231D、FD-640B、FD-640D、FD-200B、FD-200D、FD-591B、FD-591D）

K 號：K182526 · 2019-05-29

申請人Vcomin Technology Limited
決定日期2019-05-29
產品代碼KNG
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

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) is the device name listed in this FDA 510(k) record. The listed applicant is Vcomin Technology Limited. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K182526. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)?

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is Vcomin Technology Limited. The 510(k) number is K182526.

When did Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) receive FDA 510(k) clearance?

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) received FDA 510(k) clearance on 2019-05-29, under 510(k) number K182526.

Who is the listed applicant for Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)?

The FDA 510(k) record lists Vcomin Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)?

The FDA product code for Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) is KNG.

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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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