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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 K103268
Device Name OMNI EXPRESS
Applicant
Infinium Medical
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact JOHN OBRIEN
Correspondent
Infinium Medical
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact JOHN OBRIEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/04/2010
Decision Date 11/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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