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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K012647
Device Name TONOPORT V
Applicant
Par Medizintechnik GmbH
Einemstrasse 9
Berlin,  DE D-10787
Applicant Contact LOTHAR ENGEL
Correspondent
Par Medizintechnik GmbH
Einemstrasse 9
Berlin,  DE D-10787
Correspondent Contact LOTHAR ENGEL
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/13/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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