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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 K861598
Device Name INTELLIGRAPH(TM) PROGRAMMER
Applicant
Intelligent Medicine, Inc.
6665 S. Kenton, Suite 201
Englewood,  CO  80111
Applicant Contact DAVID C HOWSON
Correspondent
Intelligent Medicine, Inc.
6665 S. Kenton, Suite 201
Englewood,  CO  80111
Correspondent Contact DAVID C HOWSON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/29/1986
Decision Date 07/24/1986
Decision Substantially Equivalent (SESE)
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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