QUEST MPS BACK-UP SYSYEM

codes

Device Classification Name

pump, infusion

510(k) Number K002366
Device Name QUEST MPS BACK-UP SYSYEM
Original Applicant
QUEST MEDICAL, INC.
one allentown pkwy.
allen, 
TX 
75002

Original Contact doug bryan
Regulation Number 880.5725
Classification Product Code
FRN  
Subsequent Product Codes
DRS   DTR   DWF   DXS   KRL  
Date Received 07/27/2000
Decision Date 09/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No