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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 K820038
Device Name SIGMA 7000
Applicant
Sigma
MD 
Correspondent
Sigma
MD 
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/07/1983
Decision Date 01/26/1983
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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