FDA 510(k)

Accutension 智能手机听诊血压计

K号: K180335 · 2018-03-08

决定日期2018-03-08

产品代码DXQ

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

Accutension Smartphone Auscultatory Blood is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hulu Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K180335. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Accutension Smartphone Auscultatory Blood?

Accutension Smartphone Auscultatory Blood is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Shanghai Hulu Devices Co., Ltd.. The 510(k) number is K180335.

When did Accutension Smartphone Auscultatory Blood receive FDA 510(k) clearance?

Accutension Smartphone Auscultatory Blood received FDA 510(k) clearance on 2018-03-08, under 510(k) number K180335.

Who is the listed applicant for Accutension Smartphone Auscultatory Blood?

FDA 510(k)记录将上海华漕医疗器械有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Accutension Smartphone Auscultatory Blood?

The FDA product code for Accutension Smartphone Auscultatory Blood is DXQ.

列明Shanghai Hulu Devices 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。

K261494智能无线听诊器（STEMO310）；智能无线听诊器（STEMO710）；智能无线听诊器（STEMO720）；智能无线听诊器（STEMO730）K220470Smart Wireless Stethoscope

相关器械（代码：DXQ）

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。

K254287Medline 可重复使用血压袖带Medline Industries, LP K260747YP-710T系列血压计袖带；YP-840T系列一次性袖带Nihon Kohden Corporation K253089NIBP袖带（BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722）Shenzhen Best Electronics Co., Ltd.K253964一次性新生儿NIBP袖带（U1681S-C51N）Unimed Medical Supplies, Inc.K251745韦尔奇·艾略恩FlexiPort血压袖带（FlexiPort血压袖带）Baxter Healthcare Corporation K250765AViTA 臂式血压计袖带Avita Corporation

官方来源

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