510(k) K031983

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

K031983 is an FDA 510(k) premarket notification submitted by Inovo, Inc. for the device "INOVO, INC, ECONOMIZER CONSERVING REGULATOR". The FDA issued a decision of Substantially Equivalent on September 15, 2003. 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
September 15, 2003
Date Received
June 26, 2003
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