WARD-CSS（v1.2.x）
K号: K241958 · 2025-02-14
广告
决定日期2025-02-14
产品代码MWI
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
WARD-CSS (v1.2.x) is the device name listed in this FDA 510(k) record. The listed applicant is Ward 24/7 Aps. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K241958. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the WARD-CSS (v1.2.x)?
WARD-CSS (v1.2.x) is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Ward 24/7 Aps. The 510(k) number is K241958.
When did WARD-CSS (v1.2.x) receive FDA 510(k) clearance?
WARD-CSS (v1.2.x) received FDA 510(k) clearance on 2025-02-14, under 510(k) number K241958.
Who is the listed applicant for WARD-CSS (v1.2.x)?
The FDA 510(k) record lists Ward 24/7 Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WARD-CSS (v1.2.x)?
The FDA product code for WARD-CSS (v1.2.x) is MWI.
相关器械（代码：MWI）
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。
K260438生命体征监测仪（CLEO2）Infinium Medical, Inc.K253417Masimo 根部监测系统Masimo CorporationK253196Midmark 800 数字生命体征设备（1-300-0100，1-300-0200，1-300-0300，1-300-0400）Midmark CorporationK253436c-med0 阿尔法Cosinuss GmbHK250135WAVE 临床平台（2.0.000）Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV
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