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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 K014063
Device Name TASK FORCE MONITOR 3040
Applicant
CNSYSTEMS MEDIZINTECHNIK GMBH
BAUMKIRCHERSTRASSE 1
A-8020 GRAZ
EUROPE,  AT
Applicant Contact CHRISTIAN WAGNER
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number870.2770
Classification Product Code
DSB  
Date Received12/11/2001
Decision Date 02/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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