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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 K944721
Device Name 9000 INFUSION PUMP
Applicant
Graseby Medical , Ltd.
Colonial Way
Watford, Herts.,  GB WD24 4LG
Applicant Contact J WEYMAN
Correspondent
Graseby Medical , Ltd.
Colonial Way
Watford, Herts.,  GB WD24 4LG
Correspondent Contact J WEYMAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/23/1994
Decision Date 08/11/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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