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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 K221798
Device Name Finger Pulse Oximeter, Model: X1906P
Shenzhen Changkun Technology Co., Ltd.
Room 501, Changkun Technology Building A, 12 Shijia Roan
Biling Community, Biling Subdistrict
Shenzhen,  CN 518118
Applicant Contact Wang Qingpeng
Shenzhen Reanny Medical Devices Management Consulting., Ltd
Room 1407, Jingting Building, Dongzhou Community,
Guangming Street, Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.2700
Classification Product Code
Date Received06/21/2022
Decision Date 05/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No