Source document or public record
FDA 510(k) K242526 — Visby Medical Respiratory Health Test
FDA 510(k) index record K242526. Device: Visby Medical Respiratory Health Test. Applicant as listed: Visby Medical, Inc.. Decision date: 2025-02-19.
Source
"device_name": "Visby Medical Respiratory Health Test"
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 K242526.
Device name: Visby Medical Respiratory Health Test. Applicant as listed: Visby Medical, Inc..
Decision date: 2025-02-19. Decision wording: Substantially Equivalent.
Product code: QOF. Regulation: 21 CFR 866.3981. Medical specialty: Microbiology.
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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