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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 K003582
Device Name FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
Applicant
Fluidsense Corp.
260 Merrimac St.
Newburyport,  MA  01950
Applicant Contact THOMAS CONNELLY
Correspondent
Fluidsense Corp.
260 Merrimac St.
Newburyport,  MA  01950
Correspondent Contact THOMAS CONNELLY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/20/2000
Decision Date 12/05/2000
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
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