FDA 510(k)

P10系列数字彩色多普勒超声系统

K号: K173058 · 2017-12-01

决定日期2017-12-01

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

P10 Series Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K173058. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the P10 Series Digital Color Doppler Ultrasound System?

P10 Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K173058.

When did P10 Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

P10 Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-12-01, under 510(k) number K173058.

Who is the listed applicant for P10 Series Digital Color Doppler Ultrasound System?

FDA 510(k)记录将Sonoscape Medical Corp.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 P10 Series Digital Color Doppler Ultrasound System?

The FDA product code for P10 Series Digital Color Doppler Ultrasound System is IYN.

列明Sonoscape Medical Corp.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。

K254027数字彩色多普勒超声系统（Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90）K254028数字彩色多普勒超声系统（Autra RS，Autra 90，Autra Senior，Autra CV，e-Autra，Autra 75，Autra 85W，Autra 65，Autra 55，Autra 65i，Autra 90 Elite，Autra 85 Elite，Autra 80 Elite，Autra 75 Elite，Autra 85 CV，Autra 80W，Autra 65 Elite，Autra 55 Elite，Autra 55i，Autra 90 CV，Autra 85，Autra 80，Autra 80 CV，Autra 75 Pro，Autra 75W，Autra 70 Elite，Autra 70，Autra T）K252498数字彩色多普勒超声系统（X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU）K241949数字彩色多普勒超声系统（P60系列）K231813超声胃镜 K222596S90 Exp 系列数字彩色多普勒超声系统

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相关器械（代码：IYN）

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。

官方来源

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