510(k) K103392

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

K103392 is an FDA 510(k) premarket notification submitted by Inovo, Inc. for the device "CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER". The FDA issued a decision of Substantially Equivalent on December 17, 2010. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Inovo, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2010
Date Received
November 19, 2010
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