VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2— 510(k) K042657

Substantially Equivalent

Vioptix, Inc.

FDA 510(k) clearance K042657 for VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2, Substantially Equivalent on 2005-01-10. Applicant: Vioptix, Inc..

Clearance details

Applicant: Vioptix, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2004-09-28
Decision date: 2005-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.