FDA 510(k) Application Details - K242846

Device Classification Name	Monitor, Ultrasonic, Fetal   More FDA Info for this Device
510(K) Number	K242846
Device Name	Monitor, Ultrasonic, Fetal
Applicant	Shenzhen Bestman Instrument Co., Ltd. 8th floor, Yifang Building, No.315, Shuangming Avenue, Dongzhou Community, Guangming Street, Guangming District Shenzhen 518107 CN Other 510(k) Applications for this Company
Contact	Yong Bai 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	09/20/2024
Decision Date	06/26/2025
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