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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 K132229
Device Name OMNI PATENT MONITORS
Applicant
Infinium Medical
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact JOHN O'BRIEN
Correspondent
Infinium Medical
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact JOHN O'BRIEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/18/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
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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