FDA 510(k) Application Details - K010920

Device Classification Name	Monitor, Heart Rate, Fetal, Ultrasonic   More FDA Info for this Device
510(K) Number	K010920
Device Name	Monitor, Heart Rate, Fetal, Ultrasonic
Applicant	MEDICAL CABLES, INC. 1340 LOGAN AVE. COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	ROBERT HILMAN Other 510(k) Applications for this Contact
Regulation Number	884.2660   More FDA Info for this Regulation Number
Classification Product Code	HEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2001
Decision Date	06/22/2001
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