AIRLIFE

Nebulizer (direct Patient Interface)

CAREFUSION

The following data is part of a premarket notification filed by Carefusion with the FDA for Airlife.

Pre-market Notification Details

• Device ID: K123527
• 510k Number: K123527
• Device Name: AIRLIFE
• Classification: Nebulizer (direct Patient Interface)
• Applicant: CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60060
• Contact: Erika Fernandez
• Correspondent: Erika Fernandez; CAREFUSION 1500 WAUKEGAN ROAD Waukegan, IL 60060
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-16
• Decision Date: 2013-04-25
• Summary: summary