510(k) K060751

INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR by Inovo, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2006
Date Received
March 21, 2006
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