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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(With Arrhythmia Detection Or Alarms)
510(k) Number K112190
Device Name PATIENT MONITOR
Applicant
Mediana Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
Mediana Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/29/2011
Decision Date 11/09/2011
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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