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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 K103685
Device Name PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
Applicant
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.
P.O. BOX 237-023
SHANGAHI,  CN 200237
Applicant Contact Diana Hong
Correspondent
BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.
P.O. BOX 237-023
SHANGAHI,  CN 200237
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/17/2010
Decision Date 07/15/2011
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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