SAVINA

Ventilator, Continuous, Facility Use

DRAGER MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Drager Medizintechnik Gmbh with the FDA for Savina.

Pre-market Notification Details

• Device ID: K003068
• 510k Number: K003068
• Device Name: SAVINA
• Classification: Ventilator, Continuous, Facility Use
• Applicant: DRAGER MEDIZINTECHNIK GMBH 3136 QUARRY RD. Telford, PA 18969
• Contact: Jim Brennan
• Correspondent: Jim Brennan; DRAGER MEDIZINTECHNIK GMBH 3136 QUARRY RD. Telford, PA 18969
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-10-02
• Decision Date: 2001-06-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048675421610	K003068	000
04048675407881	K003068	000