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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, St Segment With Alarm
510(k) Number K935020
Device Name OMNI-TRAC MODIFICATION
Applicant
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Applicant Contact ROGER SUSI
Correspondent
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact ROGER SUSI
Regulation Number870.1025
Classification Product Code
MLD  
Date Received10/20/1993
Decision Date 04/26/1995
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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