FDA 510(k) Application Details - K980719

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K980719
Device Name	System, Monitoring, Perinatal
Applicant	LMS MEDICAL SYSTEMS LTD. 5252 DE MAISONNEUVE WEST, #314 MONTREAL, QC H4A 3S5 CA Other 510(k) Applications for this Company
Contact	DR. EMILY HAMILTON Other 510(k) Applications for this Contact
Regulation Number	884.2740   More FDA Info for this Regulation Number
Classification Product Code	HGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/1998
Decision Date	07/31/1998
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