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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 K101694
Model M800
Device Name HANDHELD PULSE OXIMETER MODEL M800
Original Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
suite 5d, no. 19, lane 999
zhongshan road (s-2)
shanghai,  CH 200030
Original Contact diana hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/21/2010
Decision Date 09/08/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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