510(k) K052335— ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA

Substantially Equivalent

Accutron, Inc.

Clearance details

Applicant: Accutron, Inc.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2005-08-26
Decision date: 2005-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.