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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K121424
Device Name EXPRESSION INFORMATION PORTAL
Applicant
INVIVO CORPORATION
12151 RESEARCH PKWY
ORLANDO,  FL  32826
Applicant Contact RUSTY KELLY
Correspondent
INVIVO CORPORATION
12151 RESEARCH PKWY
ORLANDO,  FL  32826
Correspondent Contact RUSTY KELLY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/14/2012
Decision Date 06/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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