510(k) K904045— #504 MINI COMPRESSOR

Substantially Equivalent

Medical Industries America, Inc.

Clearance details

Applicant: Medical Industries America, Inc.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1990-09-04
Decision date: 1991-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Adel, IA, 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.