FDA 510(k) Application Details - K040819

Device Classification Name	System, Monitoring, Perinatal   More FDA Info for this Device
510(K) Number	K040819
Device Name	System, Monitoring, Perinatal
Applicant	AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. HANOVER, MD 21076 US Other 510(k) Applications for this Company
Contact	GREGORY FALK 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	03/30/2004
Decision Date	08/16/2004
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