LifeShield 输液安全软件套件
K号: K242117 · 2025-04-02
广告
决定日期2025-04-02
产品代码PHC
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
LifeShield Infusion Safety Software Suite is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2025-04-02 under 510(k) number K242117. The device is classified under product code PHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LifeShield Infusion Safety Software Suite?
LifeShield Infusion Safety Software Suite is a medical device that received FDA 510(k) clearance on 2025-04-02. The listed applicant is Icu Medical, Inc.. The 510(k) number is K242117.
When did LifeShield Infusion Safety Software Suite receive FDA 510(k) clearance?
LifeShield Infusion Safety Software Suite received FDA 510(k) clearance on 2025-04-02, under 510(k) number K242117.
Who is the listed applicant for LifeShield Infusion Safety Software Suite?
The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LifeShield Infusion Safety Software Suite?
The FDA product code for LifeShield Infusion Safety Software Suite is PHC.
相关临床试验
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。
列明Icu Medical, 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。
相关器械（代码：PHC）
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。
K252130LifeShield 输液安全软件套件Icu Medical, Inc.K243062BD Intelliport 系统; BD Intelliport 读取器 (516230); BD Intelliport 传感器 (516229); BD Intelliport 网关 (516232); BD Intelliport 座 (516233); BD Intelliport 充电器 (516231)Becton DickinsonK230665Dose IQ Safety SoftwareBaxter Healthcare CorporationK223606LifeShield™ 输液安全软件套件Icu Medical, Inc.K211124Dose IQ Safety SoftwareBaxter Healthcare CorporationK210075Vigilant软件套件 – Vigilant Master医Fresenius Kabi AG
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告