FDA 510(k) Application Details - K211940

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K211940
Device Name	Monitor, Ultrasonic, Fetal
Applicant	Shenzhen Taikang Medical Equipment Co., Ltd. 3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park, Pingshan District Shenzhen 518015 CN Other 510(k) Applications for this Company
Contact	Shigui Du Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	KNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2021
Decision Date	01/07/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review