FDA 510(k) Application Details - K973025

Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems

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510(K) Number K973025
Device Name Monitor, Electric For Gravity Flow Infusion Systems
Applicant NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN, IL 60123 US
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Contact CASEY KUREK
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Regulation Number 880.2420

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Classification Product Code FLN
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Date Received 08/14/1997
Decision Date 11/20/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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