510(k) K052563

INOGEN SATELLITE CONSERVER, MODEL SC-100 by Medical Electronic Devices, Inc. — Product Code NFB

K052563 is an FDA 510(k) premarket notification submitted by Medical Electronic Devices, Inc. for the device "INOGEN SATELLITE CONSERVER, MODEL SC-100". The FDA issued a decision of Substantially Equivalent on October 24, 2005. 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.