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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K233823
Device Name Ultrasonic Fetal Doppler
Applicant
Shenzhen Jamr Technology Co., Ltd.
A101-301, D101-201, Jamr Science & Technology Park, #2
Guiyuan Rd., Guixiang Community
Shenzhen,  CN 518100
Applicant Contact Haiyu Zhang
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community,
Guangming St., Guangming
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number884.2660
Classification Product Code
KNG  
Date Received12/01/2023
Decision Date 06/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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