510(k) K030864— VADI MANUAL RESUSCITATOR

Substantially Equivalent

Vedi Corp.

Clearance details

Applicant: Vedi Corp.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2003-03-18
Decision date: 2004-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.