DistaSense(TM) (v1)
K号: K254058 · 2026-09-25
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器械摘要
DistaSense(TM) (v1) is the device name listed in this FDA 510(k) record. The listed applicant is Life Detection Technologies. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254058. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
DistaSense™ (v1)是什么？
DistaSense(TM) (v1) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Life Detection Technologies. The 510(k) number is K254058.
When did DistaSense(TM) (v1) receive FDA 510(k) clearance?
DistaSense(TM) (v1) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254058.
Who is the listed applicant for DistaSense(TM) (v1)?
The FDA 510(k) record lists Life Detection Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DistaSense(TM) (v1)?
The FDA product code for DistaSense(TM) (v1) is DRT.
相关临床试验
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相关器械（代码：DRT）
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。
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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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