510(k) K033197

INOGEN SATELLITE CONSERVER by Medical Electronic Devices, Inc. — Product Code NFB

K033197 is an FDA 510(k) premarket notification submitted by Medical Electronic Devices, Inc. for the device "INOGEN SATELLITE CONSERVER". The FDA issued a decision of Substantially Equivalent on May 13, 2004. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Medical Electronic Devices, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2004
Date Received
October 2, 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