FDA 510(k) Application Details - K092858

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K092858
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	SAFERSONIC MEDIZINPRODUKTE GMBH 5401 S. COTTONWOOD CT. GREENWOOD VILLAGE, CO 80121 US Other 510(k) Applications for this Company
Contact	Kevin Walls 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	09/16/2009
Decision Date	11/10/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review