Source document or public record
FDA 510(k) K243965 — Origin
FDA 510(k) index record K243965. Device: Origin. Applicant as listed: Nerv Technology Inc. (D.B.A.) Fluidai Medical. Decision date: 2025-08-21.
Source
"device_name": "Origin"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K243965.
Device name: Origin. Applicant as listed: Nerv Technology Inc. (D.B.A.) Fluidai Medical.
Decision date: 2025-08-21. Decision wording: Substantially Equivalent.
Product code: SFO. Regulation: 21 CFR 862.1120. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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