FDA 510(k)

Holter 心电图和ABP系统 (HolterABP)

K号: K251591 · 2026-02-09

决定日期2026-02-09

产品代码DQK

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

Holter ECG and ABP system (HolterABP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2026-02-09 under 510(k) number K251591. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Holter ECG and ABP system (HolterABP)?

Holter ECG and ABP system (HolterABP) is a medical device that received FDA 510(k) clearance on 2026-02-09. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251591.

When did Holter ECG and ABP system (HolterABP) receive FDA 510(k) clearance?

Holter ECG and ABP system (HolterABP) received FDA 510(k) clearance on 2026-02-09, under 510(k) number K251591.

Who is the listed applicant for Holter ECG and ABP system (HolterABP)?

FDA 510(k)记录中列出Edan Instruments, Inc.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 Holter ECG and ABP system (HolterABP)?

The FDA product code for Holter ECG and ABP system (HolterABP) is DQK.

列明Edan Instruments, Inc.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。

K251508遥测监测仪（iT30，iT50）K252463SE-1202系列心电图机（型号：SE-1202，SE-1202E）K251268诊断型超声系统（Nano C5，Nano C5 EXP，Nano L12，和 Nano L12 EXP）K241882胎儿与母体监护仪（F15A，F15A Air）K250179患者监护仪（CX10，CX12，CX15，UX10，UX12，UX15）K250214Acclarix AX8 系列诊断超声系统（型号：Acclarix AX7，Acclarix AX8，Acclarix AX75，Acclarix AX78，Acclarix AX8 Exp，Acclarix AX8 Super），Acclarix AX9 系列诊断超声系统（型号：Acclarix AX9 Basic，Acclarix AX9，Acclarix AX9 Exp，Acclarix AX9 Super，Acclarix AX85，Acclarix AX88）

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官方来源

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