S-Patch Ex Wearable ECG Patch
K号: K231289 · 2023-08-30
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器械摘要
S-Patch Ex Wearable ECG Patch is the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231289. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the S-Patch Ex Wearable ECG Patch?
S-Patch Ex Wearable ECG Patch is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Wellysis Corp.. The 510(k) number is K231289.
When did S-Patch Ex Wearable ECG Patch receive FDA 510(k) clearance?
S-Patch Ex Wearable ECG Patch received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231289.
Who is the listed applicant for S-Patch Ex Wearable ECG Patch?
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 Ex Wearable ECG Patch?
The FDA product code for S-Patch Ex Wearable ECG Patch is DSH.
相关临床试验
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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：DSH）
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。
K260157LifeLens生理监测仪LifeLens Technologies, Inc.K252389Rhythm Master 心电图贴片 (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch（ATP-C130/ATP-C70）Atsens Co., Ltd.
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。
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