K032386

Substantially Equivalent

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

Applicant: Impact Instrumentation, Inc.
Product code: BTL
Advisory panel: Anesthesiology
Date received: 2003-08-04
Decision date: 2004-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.