DistaSense(TM) (v1)
K 號：K254058 · 2026-09-25
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器材摘要
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.
常見問題
DistaSense™ (v1)是什麼？
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.
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相關器械（代碼：DRT）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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