FDA 510(k)

胎儿多普勒

K号: K212084 · 2021-11-03

申请人Shenzhen Mericonn Technology Co., Ltd.

决定日期2021-11-03

产品代码KNG

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决定实质等同

器械摘要

Fetal Doppler is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mericonn Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K212084. 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?

Fetal Doppler is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Shenzhen Mericonn Technology Co., Ltd.. The 510(k) number is K212084.

When did Fetal Doppler receive FDA 510(k) clearance?

Fetal Doppler received FDA 510(k) clearance on 2021-11-03, under 510(k) number K212084.

Who is the listed applicant for Fetal Doppler?

FDA 510(k)记录将深圳美康科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Fetal Doppler?

The FDA product code for Fetal Doppler is KNG.

列明Shenzhen Mericonn Technology 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。

K254171网状雾化器（UN204）；网状雾化器（UN205）；网状雾化器（UN209）；网状雾化器（UN210）K212300脉搏血氧仪

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 K220245口袋胎儿多普勒（型号CONTEC10C和CONTEC10CL）Contec Medical Systems Co.,Ltd K211940胎儿多普勒Shenzhen Taikang Medical Equipment Co., Ltd.

官方来源

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