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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K934543
Device Name UNIVERSAL CONTROLLER, MODEL 100
Applicant
Metamed, Inc.
5937 Balboa Ave., Suite 103
San Diego,  CA  92111
Applicant Contact HOWARD EVERHART
Correspondent
Metamed, Inc.
5937 Balboa Ave., Suite 103
San Diego,  CA  92111
Correspondent Contact HOWARD EVERHART
Regulation Number880.5725
Classification Product Code
LDR  
Date Received09/16/1993
Decision Date 03/29/1994
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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