ODISSEY TISSUE OXIMETER— 510(k) K141234

Name: FDA 510(k) clearance K141234
Creator: U.S. Food and Drug Administration
Published: 2014-07-01

Substantially Equivalent

Vioptix, Inc.

FDA 510(k) clearance K141234 for ODISSEY TISSUE OXIMETER, Substantially Equivalent on 2014-07-01. Applicant: Vioptix, Inc.. Device class: 2.

Clearance details

Applicant: Vioptix, Inc.
Product code: Code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2014-05-13
Decision date: 2014-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K163472 — Intra.Ox Handheld Tissue Oximeter2017-11-16
K133983 — INTRA. OX HANDHELD TISSUE OXIMETER2014-09-12

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.