510(k) K781213— COMPRESSOR, AIR, MINI-SILENT

Substantially Equivalent

The John Bunn Co.

Clearance details

Applicant: The John Bunn Co.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1978-07-10
Decision date: 1978-07-27
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.