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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
Applicant
Shenzhen Changkun Technology Co., Ltd.
Rm. 501, Changkun Technology Bldg. A, 12 Shijia Roan
Biling Community, Biling Subdistrict
Shenzhen,  CN 518118
Applicant Contact Wang Qingpeng
Correspondent
Shenzhen Reanny Medical Devices Management Consulting., Ltd.
Rm. 1407, Jingting Bldg., Dongzhou Community, Guangming
St., Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.2700
Classification Product Code
DQA  
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
Predetermined Change
Control Plan Authorized		 No
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