510(k) K981773

DRAGER-VAPOR 19.3 by Draeger Medical, Inc. — Product Code CAD

K981773 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "DRAGER-VAPOR 19.3". The FDA issued a decision of Substantially Equivalent on July 6, 1998. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1998
Date Received
May 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
Review Panel
AN
Submission Type