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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 K002211
Device Name COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
Applicant
Baxter Healthcare Corp
Rt. 120 & Wilson Rd.
Round Lake,  IL  60073
Applicant Contact JENNIFER M PAINE
Correspondent
Baxter Healthcare Corp
Rt. 120 & Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact JENNIFER M PAINE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/21/2000
Decision Date 07/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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