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FDA 510(k)

胎儿多普勒（型号：FD-231B、FD-231D、FD-640B、FD-640D、FD-200B、FD-200D、FD-591B和FD-591D）

K号: K182526 · 2019-05-29

申请人Vcomin Technology Limited
决定日期2019-05-29
产品代码KNG
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：KNG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252669胎儿多普勒U8-25，U9-25Zhongshan Xiaolan Town Senlan Electronic FactoryK242846多普勒 FHR 检测器（BF-500D+，BF-560）Shenzhen Bestman Instrument Co., Ltd.K233823超声波胎儿多普勒Shenzhen Jamr Technology Co., Ltd.K232893口袋胎儿多普勒（CONTEC 10D），口袋胎儿多普勒（CONTEC 10E），口袋胎儿多普勒（CONTEC 10F）Contec Medical Systems Co.,LtdK220245口袋胎儿多普勒（型号CONTEC10C和CONTEC10CL）Contec Medical Systems Co.,LtdK211940胎儿多普勒Shenzhen Taikang Medical Equipment Co., Ltd.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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