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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 K151287
Device Name Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
INNOVATION FIRST ROAD
TECHNOLOGY INNOVATION COAST
ZHUHAI,  CN 519085
Applicant Contact Jin Liang
Correspondent
MID-LINK CONSULTING CO., LTD
P.O. BOX 120-119
SHANGHAI,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/14/2015
Decision Date 01/06/2016
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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