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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K880664
Device Name MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact TIMOTHY MICKELSON
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact TIMOTHY MICKELSON
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/18/1988
Decision Date 03/09/1988
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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