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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 K121697
Model APO-8284
Device Name FINGERTIP PULSE OXIMETER
Original Applicant
ANDON HEALTH CO., LTD
no. 3 jin ping street,ya an road,
nankai district
tianjin,  CN 300190
Original Contact liu yi
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/07/2012
Decision Date 10/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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