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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K100225
Device Name PULSE OXIMETER MODEL P10
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 Number870.2700
Classification Product Code
DQA  
Date Received01/26/2010
Decision Date 02/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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