Source document or public record
FDA 510(k) K222280 — Bigfoot Unity® Diabetes Management System
FDA 510(k) index record K222280. Device: Bigfoot Unity® Diabetes Management System. Applicant as listed: Bigfoot Biomedical, Inc.. Decision date: 2023-03-01.
Source
"device_name": "Bigfoot Unity® Diabetes Management System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K222280.
Device name: Bigfoot Unity® Diabetes Management System. Applicant as listed: Bigfoot Biomedical, Inc..
Decision date: 2023-03-01. Decision wording: Substantially Equivalent.
Product code: QLG. Regulation: 21 CFR 862.1355. 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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