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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K841374
Device Name HOME PRO VOLUMETRIC INFUSION PUMP
Applicant
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Applicant Contact DAINA GRAHAM
Correspondent
AMERICAN EDWARDS LABORATORIES
P.O. BOX 11150
17221 RED HILL AVE.(IRVINE)
SANTA ANA,  CA  92711 -1150
Correspondent Contact DAINA GRAHAM
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/03/1984
Decision Date 02/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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