EVITA

Ventilator, Continuous, Facility Use

DRAGER, INC.

The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Evita.

Pre-market Notification Details

• Device ID: K924930
• 510k Number: K924930
• Device Name: EVITA
• Classification: Ventilator, Continuous, Facility Use
• Applicant: DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 Chantilly, VA 22021
• Contact: Stefan Frembgen
• Correspondent: Stefan Frembgen; DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 Chantilly, VA 22021
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-09-30
• Decision Date: 1994-01-10
• Summary: summary