Cleared Traditional

ODI-Tech

K241393 · Odi Medical AS · General & Plastic Surgery
Aug 2024
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K241393 is an FDA 510(k) clearance for the ODI-Tech, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Odi Medical AS (Oslo, NO). The FDA issued a Cleared decision on August 30, 2024, 106 days after receiving the submission on May 16, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K241393 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2024
Decision Date August 30, 2024
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700