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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K895111
Device Name TYPE 9541 RECORDER, PAPER CHART
Applicant
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Applicant Contact LISBETH ISBRANDT
Correspondent
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Correspondent Contact LISBETH ISBRANDT
Regulation Number870.2810
Classification Product Code
DSF  
Date Received08/03/1989
Decision Date 01/26/1990
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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