FDA 510(k) Application Details - K013281

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K013281
Device Name	System, Monitoring, Perinatal
Applicant	NICOLET BIOMEDICAL 6355 JOYCE DR. GOLDEN, CO 80403 US Other 510(k) Applications for this Company
Contact	DAVID W WAGNER 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	10/02/2001
Decision Date	04/18/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review