MACS CPAP SYSTEM— 510(k) K080692

Name: FDA 510(k) clearance K080692
Creator: U.S. Food and Drug Administration
Published: 2008-06-20

Substantially Equivalent

Airon Corporation

FDA 510(k) clearance K080692 for MACS CPAP SYSTEM, Substantially Equivalent on 2008-06-20. Applicant: Airon Corporation. Device class: 2.

Clearance details

Applicant: Airon Corporation
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
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 ↗

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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.