510(k) K983601

DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC by Medical Electronic Devices, Inc. — Product Code NFB

K983601 is an FDA 510(k) premarket notification submitted by Medical Electronic Devices, Inc. for the device "DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC". The FDA issued a decision of Substantially Equivalent on December 15, 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.