FDA 510(k)

VS 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

K号: K221267 · 2022-12-15

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

决定日期2022-12-15

产品代码MWI

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor 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 2022-12-15 under 510(k) number K221267. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K221267.

When did VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor receive FDA 510(k) clearance?

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221267.

Who is the listed applicant for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

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 VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

The FDA product code for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is MWI.

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。

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 K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB 诊断超声系统 K170712Accutorr 7/VS-900 生命体征监测仪

官方来源

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