510(k) K113111

CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION by Inovo, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2011
Date Received
October 20, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type