510(k) K051540

INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR by Inovo, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2005
Date Received
June 10, 2005
Clearance Type
Traditional
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