ODI-Tech— 510(k) K241393

Name: FDA 510(k) clearance K241393
Creator: U.S. Food and Drug Administration
Published: 2024-08-30

Substantially Equivalent

Odi Medical AS

FDA 510(k) clearance K241393 for ODI-Tech, Substantially Equivalent on 2024-08-30. Applicant: Odi Medical AS. Device class: 2.

Clearance details

Applicant: Odi Medical AS
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2024-05-16
Decision date: 2024-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oslo, NO

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUD

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K254129 — Spectrum-22026-05-22
K243324 — Masimo O3 Regional Oximeter2025-07-17
K250519 — Lap.Ox Laparoscopic Tissue Oximeter2025-06-26
K240596 — Cerebral Autoregulation Index (CAI) Algorithm2024-10-16
K240601 — SnapshotNIR model KD2052024-04-02

Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.