Sentec 数字监控系统（SDMS）tCOM+
K号: K232516 · 2024-05-17
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申请人Sentec AG
决定日期2024-05-17
产品代码LKD
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Sentec Digital Monitoring System (SDMS) tCOM+ is the device name listed in this FDA 510(k) record. The listed applicant is Sentec AG. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K232516. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sentec Digital Monitoring System (SDMS) tCOM+?
Sentec Digital Monitoring System (SDMS) tCOM+ is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Sentec AG. The 510(k) number is K232516.
When did Sentec Digital Monitoring System (SDMS) tCOM+ receive FDA 510(k) clearance?
Sentec Digital Monitoring System (SDMS) tCOM+ received FDA 510(k) clearance on 2024-05-17, under 510(k) number K232516.
Who is the listed applicant for Sentec Digital Monitoring System (SDMS) tCOM+?
The FDA 510(k) record lists Sentec AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sentec Digital Monitoring System (SDMS) tCOM+?
The FDA product code for Sentec Digital Monitoring System (SDMS) tCOM+ is LKD.
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列明Sentec AG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。
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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