MACS CPAP SYSTEM— 510(k) K080692

Substantially Equivalent

Airon Corporation

FDA 510(k) clearance K080692 for MACS CPAP SYSTEM, Substantially Equivalent on 2008-06-20. Applicant: Airon Corporation.

Clearance details

Applicant: Airon Corporation
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2008-03-11
Decision date: 2008-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.