FDA 510(k) Application Details - K020390

Device Classification Name	Home Uterine Activity Monitor   More FDA Info for this Device
510(K) Number	K020390
Device Name	Home Uterine Activity Monitor
Applicant	HUNTLEIGH DIAGNOSTICS LTD. 40 CHRISTOPHER WAY EATONTOWN, NJ 07724-3327 US Other 510(k) Applications for this Company
Contact	AUDREY WITKO 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	02/06/2002
Decision Date	04/19/2002
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