Origin— 510(k) K243965

Name: FDA 510(k) clearance K243965
Creator: U.S. Food and Drug Administration
Published: 2025-08-21

Substantially Equivalent

Nerv Technology Inc. (D.B.A.) Fluidai Medical

FDA 510(k) clearance K243965 for Origin, Substantially Equivalent on 2025-08-21. Applicant: Nerv Technology Inc. (D.B.A.) Fluidai Medical. Device class: 2.

Clearance details

Applicant: Nerv Technology Inc. (D.B.A.) Fluidai Medical
Product code: Code SFO
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 2024-12-23
Decision date: 2025-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kitchener, CA

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