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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 K172792
Device Name Handheld Pulse Oximeter, Model SP-20
Applicant
Shenzhen Creative Industry Co., Ltd.
2/F, Block 3, Nanyou Tian'An Industry Town
Shenzhen,  CN 518054
Applicant Contact Jia Wang
Correspondent
Irc
2091 Oak Dr.
Lake Havasu City,  AZ  86406
Correspondent Contact Charlie Mack
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
FLL  
Date Received09/15/2017
Decision Date 11/13/2018
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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