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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 K082846
Device Name APK SPO2 PULSE OXIMETER SENSOR
Applicant
APK TECHNOLOGY CO., LTD
SUITE 8D, NO19, ZHONGSHAN
MANSION, LANE 999, ZHONGSHAN
NO. 2 ROAD(S); SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
APK TECHNOLOGY CO., LTD
SUITE 8D, NO19, ZHONGSHAN
MANSION, LANE 999, ZHONGSHAN
NO. 2 ROAD(S); SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/29/2008
Decision Date 04/03/2009
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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