D-VAPOR

Vaporizer, Anesthesia, Non-heated

DRAEGER MEDICAL, INC.

The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for D-vapor.

Pre-market Notification Details

• Device ID: K042276
• 510k Number: K042276
• Device Name: D-VAPOR
• Classification: Vaporizer, Anesthesia, Non-heated
• Applicant: DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969
• Contact: Gale E Winarsky
• Correspondent: Gale E Winarsky; DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969
• Product Code: CAD
• CFR Regulation Number: 868.5880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-23
• Decision Date: 2004-09-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048675301370	K042276	000
04048675225195	K042276	000