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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 K960512
Device Name GEMINI PC-ITX
Applicant
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131
Applicant Contact DALE COLEMAN
Correspondent
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131
Correspondent Contact DALE COLEMAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/05/1996
Decision Date 11/21/1996
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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