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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 -1699
Applicant Contact DALE COLEMAN
Correspondent
IMED CORP.
9775 BUSINESSPARK AVE.
SAN DIEGO,  CA  92131 -1699
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
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