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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 K113727
Model S0010B-S, S01361-S, S0136J-L, S0010J-S, S0044J-S, S0026M-L, S0010M-L
Device Name SHENZHEN MED-LINK PULSE OXIMETER PROBE
Original Applicant
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
144 research drive
hampton,  VA  23666
Original Contact rhonda alexander
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/19/2011
Decision Date 03/21/2013
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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