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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, JIN PING STREET YA AN RD
NANKAI DISTRICT
TIANJIN,  CN 300190
Applicant Contact LIU Yi
Correspondent
ANDON HEALTH CO.,LTD
#3, JIN PING STREET YA AN 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
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