510(k) K983459

PULSED OXYGEN CONSERVING DEVICE, POCD by Medical Electronic Devices, Inc. — Product Code NFB

K983459 is an FDA 510(k) premarket notification submitted by Medical Electronic Devices, Inc. for the device "PULSED OXYGEN CONSERVING DEVICE, POCD". The FDA issued a decision of Substantially Equivalent on December 8, 1998. 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.