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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 K131111
Device Name IHEALTH FINGERTIP PULSE OXIMETER
Applicant
Andon Health Co, Ltd.
#3 Jinping St., Yaan Rd., Nankai District
Tianjin,  CN 300190
Applicant Contact LIU Yi
Correspondent
Andon Health Co, Ltd.
#3 Jinping St., Yaan Rd., Nankai District
Tianjin,  CN 300190
Correspondent Contact LIU Yi
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/19/2013
Decision Date 09/11/2013
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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