510(k) K060382

FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 by Ameriflo Corp. — Product Code NFB

K060382 is an FDA 510(k) premarket notification submitted by Ameriflo Corp. for the device "FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1". The FDA issued a decision of Substantially Equivalent on April 19, 2006. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. Ameriflo Corp. has at least 1 other 510(k) clearance on record.