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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
Predetermined Change
Control Plan Authorized		 No
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