FDA 510(k) Application Details - K965008

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K965008
Device Name	System, Monitoring, Perinatal
Applicant	SPACELABS MEDICAL, INC. 925 SHERMAN AVE. HAMDEN, CT 06514 US Other 510(k) Applications for this Company
Contact	ANTHONY CALDERONI 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	12/16/1996
Decision Date	12/16/1997
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