Source document or public record
FDA 510(k) K234055 — DEKA Loop
FDA 510(k) index record K234055. Device: DEKA Loop. Applicant as listed: Deka Research and Development. Decision date: 2024-03-13.
Source
"device_name": "DEKA Loop"
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 K234055.
Device name: DEKA Loop. Applicant as listed: Deka Research and Development.
Decision date: 2024-03-13. Decision wording: Substantially Equivalent.
Product code: QJI. Regulation: 21 CFR 862.1356. 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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