CPAP BLOWER— 510(k) K853944

Name: FDA 510(k) clearance K853944
Creator: U.S. Food and Drug Administration
Published: 1985-11-21

Substantially Equivalent

American Air & Process, Inc.

FDA 510(k) clearance K853944 for CPAP BLOWER, Substantially Equivalent on 1985-11-21. Applicant: American Air & Process, Inc.. Device class: 2.

Clearance details

Applicant: American Air & Process, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1985-09-24
Decision date: 1985-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MO, US

Download summary PDF View on FDA.gov ↗

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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.