FDA 510(k)

DistaSense(TM) (v1)

Номер K: K254058 · 2026-09-25

Дата решения2026-09-25

Код продуктаDRT

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

Что такое DistaSense(TM) (v1)?

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: DRT)

K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.

Официальный источник

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