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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 K201468
Device Name Pulse Oximeter
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9 Baiwangxin High-Tech Industrial Park
Songbai Road, Xili Street
Shenzhen,  CN 518110
Applicant Contact Jia Wang
International Regulatory Consultants (IRC)
2950 E Lindrick Drive
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number870.2700
Classification Product Code
Date Received06/02/2020
Decision Date 01/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No