EVITA 2 DURA

Ventilator, Continuous, Facility Use

DRAGER, INC.

The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Evita 2 Dura.

Pre-market Notification Details

• Device ID: K970165
• 510k Number: K970165
• Device Name: EVITA 2 DURA
• Classification: Ventilator, Continuous, Facility Use
• Applicant: DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 Chantilly, VA 22021
• Contact: Harold Kneuer
• Correspondent: Harold Kneuer; DRAGER, INC. 4101 PLEASENT VALLEY ROAD, SUITE 100 Chantilly, VA 22021
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Se Subject To Tracking Reg (ST)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-16
• Decision Date: 1997-08-26
• Summary: summary