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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 K192343
Device Name Patient Monitor
Applicant
Shenzhen Creative Industry Co., Ltd.
Floor 5, Bld 9 Baiwangxin High-Tech Industrial Park
Songbai Rd., Xili St.
Shenzhen,  CN 518110
Applicant Contact Jia Wang
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
CCK   DXN   FLL   MWI  
Date Received08/28/2019
Decision Date 12/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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