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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K050783
Device Name ISSYS DRUG FLOW MONITOR
Applicant
Integrated Sensing Systems, Inc.
391 Airport Industrial Dr.
Ypsilanti,  MI  48198
Applicant Contact STEPHEN GOLDNER, JD, RAC
Correspondent
Integrated Sensing Systems, Inc.
391 Airport Industrial Dr.
Ypsilanti,  MI  48198
Correspondent Contact STEPHEN GOLDNER, JD, RAC
Regulation Number880.2420
Classification Product Code
FLN  
Date Received03/28/2005
Decision Date 02/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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