510(k) K853944— CPAP BLOWER

Substantially Equivalent

American Air & Process, Inc.

Clearance details

Applicant: American Air & Process, Inc.
Product code: Code BTI
Advisory panel: Anesthesiology
Date received: 1985-09-24
Decision date: 1985-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MO, 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.