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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 K120502
Device Name PC-60NW FINGERTIP OXIMETER
Applicant
SHENZHEN CREATIVE INDUSTRY CO., LTD
77325 JOYCE WAY
ECHO,  OR  97826
Applicant Contact CHARLES MACK
Correspondent
SHENZHEN CREATIVE INDUSTRY CO., LTD
77325 JOYCE WAY
ECHO,  OR  97826
Correspondent Contact CHARLES MACK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/21/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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