510(k) K132903

DRE VENTURA by Dre Medical, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2014
Date Received
September 16, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type