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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K040228
Device Name MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
Applicant
Medi-Stim A/S
7601 Northland Dr.
Mailstop A150
Brooklyn Park,  MN  55428
Applicant Contact JON H HOEM
Correspondent
Medi-Stim A/S
7601 Northland Dr.
Mailstop A150
Brooklyn Park,  MN  55428
Correspondent Contact JON H HOEM
Regulation Number870.2100
Classification Product Code
DPW  
Date Received02/02/2004
Decision Date 04/29/2004
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
Recalls CDRH Recalls
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