FDA 510(k)

超声波多普勒（型号 YM-2T8）

K号: K180419 · 2018-07-19

申请人Shenzhen Imdk Medical Technology Co., Ltd.

决定日期2018-07-19

产品代码KNG

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决定实质等同

器械摘要

Ultrasonic Doppler (Model YM-2T8) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) number K180419. 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 Ultrasonic Doppler (Model YM-2T8)?

Ultrasonic Doppler (Model YM-2T8) is a medical device that received FDA 510(k) clearance on 2018-07-19. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K180419.

When did Ultrasonic Doppler (Model YM-2T8) receive FDA 510(k) clearance?

Ultrasonic Doppler (Model YM-2T8) received FDA 510(k) clearance on 2018-07-19, under 510(k) number K180419.

Who is the listed applicant for Ultrasonic Doppler (Model YM-2T8)?

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

What is the FDA product code for Ultrasonic Doppler (Model YM-2T8)?

The FDA product code for Ultrasonic Doppler (Model YM-2T8) is KNG.

列明Shenzhen Imdk Medical 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。

K252655脉搏血氧仪（PO-A2AO，PO-A2AT，PO-A3AO，PO-H1AO，PO-B1AO，PO-C5AO，PO-C5AT，PO-C6AO， PO-C6AT）K253133腕式血压计（BPM-W1VL）K243118上臂血压计 (型号: BPM-A7VL)K233040EMS/TENS按摩器设备 K221979脉搏血氧仪（型号C101A2，C101B1，C101A3）K173123脉搏血氧仪

查看所有 7 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 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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