FDA 510(k)

口袋胎儿多普勒（型号CONTEC10C和CONTEC10CL）

K号: K220245 · 2022-09-28

决定日期2022-09-28

产品代码KNG

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决定实质等同

器械摘要

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) 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 2022-09-28 under 510(k) number K220245. 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 Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)?

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K220245.

When did Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) receive FDA 510(k) clearance?

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) received FDA 510(k) clearance on 2022-09-28, under 510(k) number K220245.

Who is the listed applicant for Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)?

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 (Models CONTEC10C and CONTEC10CL)?

The FDA product code for Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is KNG.

列明Contec Medical Systems Co.,Ltd为申报人的其他记录

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。

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）K232895B-Ultrasound 诊断系统 K232908彩色多普勒超声诊断系统（CMS1700B），彩色多普勒超声诊断系统（CMS1700C）K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor K201980红外体温计 K171360CONTEC™ Electrocardiograph

查看所有 10 个设备 →

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 Factory K242846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.,Ltd K211940胎儿多普勒Shenzhen Taikang Medical Equipment Co., Ltd.K212084胎儿多普勒Shenzhen Mericonn Technology Co., Ltd.

官方来源

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