FDA 510(k)

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB 诊断超声系统

K号: K171233 · 2017-09-12

申请人Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

决定日期2017-09-12

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171233. 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 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System?

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K171233.

When did Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System receive FDA 510(k) clearance?

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171233.

Who is the listed applicant for Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System?

The FDA product code for Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System is IYN.

列明Shenzhen Mindray Bio-Meidcal Electronics 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。

K221267VS 8 生命体征监测仪，VS 8A 生命体征监测仪，VS 9 生命体征监测仪 K222754ViewMate 多普勒超声系统 K202785Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y 诊断超声系统 K173369DC-30/DC-32/DC-28/DC-26/DC-25 诊断超声系统 K170712Accutorr 7/VS-900 生命体征监测仪

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。

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