510(k) K952267— CRITERION, CRITERION I.V., MODIFIED

Substantially Equivalent

Nova-Ventrx

Clearance details

Applicant: Nova-Ventrx
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1995-05-15
Decision date: 1997-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.