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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K022618
Device Name X-SCRIBE II
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Applicant Contact HARLAN VAN MATRE
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Correspondent Contact HARLAN VAN MATRE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/07/2002
Decision Date 09/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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