510(k) K191676— Intra.Ox 2.0 Handheld Tissue Oximeter

Substantially Equivalent

Vioptix, Inc.

Clearance details

Applicant: Vioptix, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2019-06-24
Decision date: 2019-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, CA, US

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.