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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K060135
Device Name MORTARA SURVEYOR TELEMETRY CENTRAL STATION
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224 -3431
Applicant Contact HARLAN L VAN MATRE
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224 -3431
Correspondent Contact HARLAN L VAN MATRE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/19/2006
Decision Date 05/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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