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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
510(k) Number K972242
Device Name REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM
Applicant
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Applicant Contact NORA K HADDING
Correspondent
Medtronic Vascular
7000 Central Ave., NE
Minneapolis,  MN  55432
Correspondent Contact NORA K HADDING
Regulation Number870.2800
Classification Product Code
MXC  
Date Received06/16/1997
Decision Date 01/16/1998
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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