FDA 510(k) Application Details - K041637

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K041637
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	ENVISIONEERING, LLC. 1982 INNERBELT BUSINESS CTR DR ST. LOUIS, MO 63114 US Other 510(k) Applications for this Company
Contact	TOM KAPPEL Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2004
Decision Date	09/01/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review