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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2006
Date Received
February 14, 2006
Clearance Type
Special
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