STS
K号: K240293 · 2024-09-17
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决定日期2024-09-17
产品代码BZC
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
STS is the device name listed in this FDA 510(k) record. The listed applicant is Techbopulm, Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) number K240293. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the STS?
STS is a medical device that received FDA 510(k) clearance on 2024-09-17. The listed applicant is Techbopulm, Ltd.. The 510(k) number is K240293.
When did STS receive FDA 510(k) clearance?
STS received FDA 510(k) clearance on 2024-09-17, under 510(k) number K240293.
Who is the listed applicant for STS?
The FDA 510(k) record lists Techbopulm, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STS?
The FDA product code for STS is BZC.
相关 PubMed 文献
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。
PMID：41450770目前针对直接面向消费者的基于微生物组的检测的监管框架是否足以保护消费者免受医疗、经济和尊严伤害？Journal of law and the biosciences ()PMID：40801347基于环介导等温扩增（LAMP）的微生物检测：FDA授权测试的综述和未来展望。Critical reviews in clinical laboratory sciences ()PMID：36314006眼科医生对人工智能可用性的接受度和认知（APPRAISE）：多国视角Frontiers in medicine ()PMID：29659675面对不可避免：为实验室开发测试的监管要求做好准备。American journal of clinical pathology ()
相关器械（代码：BZC）
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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