DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Colorado Medtech, Inc.
Product code
Code CAW
Device class
Class 2
Regulation
21 CFR 868.5440
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CAW

view all

More clearances from Colorado Medtech, Inc.

view all

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, through . 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.