FDA 510(k)

SRX 手持多普勒，DMX 手持多普勒，产科探头，血管探头

K号: K183574 · 2019-09-06

决定日期2019-09-06

产品代码DPW

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

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183574. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K183574.

When did SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes receive FDA 510(k) clearance?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183574.

Who is the listed applicant for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

The FDA 510(k) record lists Huntleigh Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

The FDA product code for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is DPW.

列明Huntleigh Healthcare , 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。

K250777Sonicaid Team3 K241368Sonicaid Team3 K211200伤口表达 K152228Hydroven 12，Hydroven 12服装

相关器械（代码：DPW）

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。

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics Medical K251904VascuChek 套件，VascuChek 收发器，VascuChek 临床探头，VascuChek 扬声器底座（VC-KIT-02，VC-TRX-02，VC-CP-01，VC-SD-01）；VascuChek 套件，VascuChek 收发器，VascuChek 外科探头，VascuChek 扬声器底座（VC-KIT-02，VC-TRX-02，VC-SP-01，VC-SD-01）Remington Medical, Inc.K251114FloPatch FP120Flosonics Medical K243852Elfor-LElfi-Tech , Ltd.K241583VascuChek 套件，VascuChek 收发器，VascuChek 临床探头，VascuChek 充电器（VC-KIT-01，VC-TRX-01，VC-CP-01，VC-CH-01）；VascuChek 套件，VascuChek 收发器，VascuChek 外科探头，VascuChek 充电器（VC-KIT-01，VC-TRX-01，VC-SP-01，VC-CH-01）Remington Medical, Inc.

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