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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 K111494
Device Name HANDHELD PULSE OXIMETER
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
FLOOR 4, JINGYANG BLDG, NO.15
XIJING RD.
SHIJINGSHAN DISTRICT, BEIJING,  CN 100041
Applicant Contact SUNNY WANG
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
FLOOR 4, JINGYANG BLDG, NO.15
XIJING RD.
SHIJINGSHAN DISTRICT, BEIJING,  CN 100041
Correspondent Contact SUNNY WANG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/31/2011
Decision Date 01/18/2012
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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