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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 K880479
Device Name IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP
Applicant
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131
Applicant Contact JARBOE, PHD
Correspondent
Imed Corp.
9775 Businesspark Ave.
San Diego,  CA  92131
Correspondent Contact JARBOE, PHD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/05/1988
Decision Date 04/25/1988
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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