FRESH AIR— 510(k) K981047

Substantially Equivalent

Colorado Medtech, Inc.

FDA 510(k) clearance K981047 for FRESH AIR, Substantially Equivalent on 1999-09-16. Applicant: Colorado Medtech, Inc..

Clearance details

Applicant: Colorado Medtech, Inc.
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1998-03-20
Decision date: 1999-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.