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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 K023491
Device Name AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
Applicant
Help Technologies
24312 Armada Dr.
Dana Point,  CA  92629
Applicant Contact ROBERT J BARD
Correspondent
Help Technologies
24312 Armada Dr.
Dana Point,  CA  92629
Correspondent Contact ROBERT J BARD
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MEA  
Date Received10/17/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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