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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K970570
Device Name NIVP3 (WINDOWS VERSION OF NIVP
Applicant
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Applicant Contact D. E HOKANSON
Correspondent
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Correspondent Contact D. E HOKANSON
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/14/1997
Decision Date 10/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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