VIANOX DELIVERY SYSTEM, MODEL II— 510(k) K033779

Substantially Equivalent

Pulmonox Medical, Inc.

FDA 510(k) clearance K033779 for VIANOX DELIVERY SYSTEM, MODEL II, Substantially Equivalent on 2004-01-26. Applicant: Pulmonox Medical, Inc..

Clearance details

Applicant: Pulmonox Medical, Inc.
Product code: Code MRN
Advisory panel: Anesthesiology
Date received: 2003-12-04
Decision date: 2004-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Edmonton, Ab, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code MRN

product code MRN

Death: 9
Malfunction: 910
Total: 919

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.