510(k) K973051

DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS by Draeger Medical, Inc. — Product Code CAD

K973051 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS". The FDA issued a decision of Substantially Equivalent on October 30, 1997. 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
October 30, 1997
Date Received
August 15, 1997
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