AVEA

Ventilator, Continuous, Facility Use

BIRD PRODUCTS CORP.

The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Avea.

Pre-market Notification Details

• Device ID: K013642
• 510k Number: K013642
• Device Name: AVEA
• Classification: Ventilator, Continuous, Facility Use
• Applicant: BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262
• Contact: Tom Gutierrez
• Correspondent: Tom Gutierrez; BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-11-05
• Decision Date: 2002-05-22
• Summary: summary