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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 K211940
Device Name Fetal Doppler
Applicant
Shenzhen Taikang Medical Equipment Co., Ltd.
3f E., Bldg. 4, Lanzhu E. Rd. 8, Grand Industrial
Park, Pingshan District
Shenzhen,  CN 518015
Applicant Contact Shigui Du
Correspondent
Shenzhen Taikang Medical Equipment Co., Ltd.
3f E., Bldg. 4, Lanzhu E. Rd. 8, Grand Industrial
Park, Pingshan District
Shenzhen,  CN 518015
Correspondent Contact Shigui Du
Regulation Number884.2660
Classification Product Code
KNG  
Date Received06/23/2021
Decision Date 01/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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