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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 K081712
Device Name FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700
Original Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
zhongshan no. 2 rd., ln 999
suite 8d, no. 19
shanghai,  CN 200030
Original Contact diana hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/17/2008
Decision Date 09/12/2008
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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