FDA 510(k) Application Details - K102263

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K102263
Device Name	System, Monitoring, Perinatal
Applicant	MCKESSON INFORMATION SOLUTIONS LLC 1835 MARKET ST. 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	STEVEN B DATLOF 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	08/10/2010
Decision Date	05/05/2011
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