FDA 510(k) Application Details - K100797

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K100797
Device Name	System, Monitoring, Perinatal
Applicant	EDAN INSTRUMENTS, INC. 55 Northern Blvd Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	JIGAR SHAH 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	03/22/2010
Decision Date	11/10/2010
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