FDA 510(k)

Aulisa脉搏血氧仪模块（第2代）（GA-OM0007, GA-OM0008）

K号: K233963 · 2025-02-25

申请人Taiwan Aulisa Medical Devices Technologies, Inc.

决定日期2025-02-25

产品代码DQA

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

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2025-02-25 under 510(k) number K233963. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K233963.

When did Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) receive FDA 510(k) clearance?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) received FDA 510(k) clearance on 2025-02-25, under 510(k) number K233963.

Who is the listed applicant for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

The FDA 510(k) record lists Taiwan Aulisa Medical Devices Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

The FDA product code for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is DQA.

列明Taiwan Aulisa Medical Devices Technologies, 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。

K233956Aulisa婴儿脉搏血氧仪模块（第2代）（GA-OM0018）K240220Aulisa温度模块（TM0002）K203208Guardian Angel Rx GA2000 系列数字生命体征监测系统 K202497Aulisa多患者数字生命体征监测系统 K191207Guardian Angel Rx GA2001 数字生命体征监测系统 K183067Guardian Angel Rx GA2000 数字生命体征监测系统

查看所有 9 个设备 →

相关器械（代码：DQA）

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。

K252821可重复使用成人SpO2夹式传感器（3m）（M1196A）；可重复使用成人SpO2夹式传感器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbH K252655脉搏血氧仪（PO-A2AO，PO-A2AT，PO-A3AO，PO-H1AO，PO-B1AO，PO-C5AO，PO-C5AT，PO-C6AO， PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2传感器（989803205381）；鼻翼SpO2传感器（989803205391）；鼻翼Sp02传感器（989803205401）Philips Medizin Systeme K260931Unimed可重复使用指夹式SpO2传感器（U403-49R和U103-49R）Unimed Medical Supplies, Inc.K252448AViTA 脉搏血氧仪 (SP61)Avita Corporation K252805优威尔®指夹式脉搏血氧仪（YX105，YX106，YX110，YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

官方来源

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