S-Patch CardioAI
K号: K254255 · 2026-09-25
广告
器械摘要
S-Patch CardioAI is the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254255. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the S-Patch CardioAI?
S-Patch CardioAI is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Wellysis Corp.. The 510(k) number is K254255.
When did S-Patch CardioAI receive FDA 510(k) clearance?
S-Patch CardioAI received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254255.
Who is the listed applicant for S-Patch CardioAI?
The FDA 510(k) record lists Wellysis Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for S-Patch CardioAI?
S-Patch CardioAI的FDA产品代码为DPS。
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Wellysis Corp.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：DPS）
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。
K252463SE-1202系列心电图机（型号：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 静息心电图分析系统Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.
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