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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 K150093
Device Name Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
Applicant
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3, Nanyou Tian'An Industry Town
Shenzhen City,  CN 518054
Applicant Contact JIA WANG
Correspondent
Irc
12226 Washington Lane
Echo,  AZ  85344
Correspondent Contact CHARLES MACK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/16/2015
Decision Date 06/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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