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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 K042121
Device Name SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
Applicant
SIGMA INTL.
711 PARK AVE.
MEDINA,  NY  14103 -0756
Applicant Contact CHARLES L MARTINA
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DERWYN REUBER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/06/2004
Decision Date 08/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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