FDA 510(k)

口袋胎兒多普勒 (CONTEC 10D)，口袋胎兒多普勒 (CONTEC 10E)，口袋胎兒多普勒 (CONTEC 10F)

K 號：K232893 · 2024-06-14

決定日期2024-06-14

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

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K232893. 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 Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)?

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K232893.

When did Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) receive FDA 510(k) clearance?

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) received FDA 510(k) clearance on 2024-06-14, under 510(k) number K232893.

Who is the listed applicant for Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)?

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

What is the FDA product code for Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)?

The FDA product code for Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) is KNG.

其他以 Contec Medical Systems 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。

K232895B-Ultrasound 診斷系統 K232908顏色多普勒超音波診斷系統（CMS1700B），顏色多普勒超音波診斷系統（CMS1700C）K220245口袋胎兒多普勒（型號CONTEC10C和CONTEC10CL）K202757CONTEC08A 電子血壓計，CONTEC08C 電子血壓計，ABPM50 自動血壓監測器 K201980紅外線體溫計 K171360CONTEC™ 心電圖機

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相關器械（代碼：KNG）

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。

K252669胎兒多普勒U8-25，U9-25Zhongshan Xiaolan Town Senlan Electronic Factory K242846多普勒胎心監測器（BF-500D+、BF-560）Shenzhen Bestman Instrument Co., Ltd.K233823超聲波嬰兒多普勒Shenzhen Jamr Technology Co., Ltd.K220245口袋胎兒多普勒（型號CONTEC10C和CONTEC10CL）Contec Medical Systems Co.,Ltd K211940胎兒多普勒Shenzhen Taikang Medical Equipment Co., Ltd.K212084胎兒多普勒Shenzhen Mericonn Technology Co., Ltd.

官方來源

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