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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 K112804
Device Name FINGERTIP PULSE OXIMETER
Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Applicant Contact Diana Hong
Correspondent
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
P.O. BOX 237-023
SHANGHAI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/27/2011
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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