FRESH AIR

Generator, Oxygen, Portable

COLORADO MEDTECH, INC.

The following data is part of a premarket notification filed by Colorado Medtech, Inc. with the FDA for Fresh Air.

Pre-market Notification Details

• Device ID: K981047
• 510k Number: K981047
• Device Name: FRESH AIR
• Classification: Generator, Oxygen, Portable
• Applicant: COLORADO MEDTECH, INC. 6175 LONGBOW DR. Boulder, CO 80301
• Contact: Lockett E Wood
• Correspondent: Lockett E Wood; COLORADO MEDTECH, INC. 6175 LONGBOW DR. Boulder, CO 80301
• Product Code: CAW
• CFR Regulation Number: 868.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-20
• Decision Date: 1999-09-16