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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K896034
Device Name PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM
Applicant
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Applicant Contact EUGENE HOKANSON
Correspondent
D. E. Hokanson, Inc.
12840 NE 21st Pl.
Bellevue,  WA  98005
Correspondent Contact EUGENE HOKANSON
Regulation Number870.2770
Classification Product Code
DSB  
Date Received10/16/1989
Decision Date 01/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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