FDA 510(k) Application Details - K042619

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K042619
Device Name	Media,Coupling,Ultrasound
Applicant	SONOTECH, INC. 774 MARINE DR. BELLINGHAM, WA 98225 US Other 510(k) Applications for this Company
Contact	MARGARET J LARSON Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2004
Decision Date	11/05/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review