FDA 510(k) Application Details - K210025

Device Classification Name	Home Uterine Activity Monitor   More FDA Info for this Device
510(K) Number	K210025
Device Name	Home Uterine Activity Monitor
Applicant	Nuvo-Group Ltd. Yigal Alon 94. St, Alon Tower 1 Tel Aviv 6789155 IL Other 510(k) Applications for this Company
Contact	Chen Rubinstein Other 510(k) Applications for this Contact
Regulation Number	884.2730   More FDA Info for this Regulation Number
Classification Product Code	LQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2021
Decision Date	05/28/2021
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