510(k) K820079— AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL

Substantially Equivalent

James L. Geraci & Associates, Inc.

Clearance details

Applicant: James L. Geraci & Associates, Inc.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1982-01-12
Decision date: 1982-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.