FDA 510(k) Application Details - K090465

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K090465
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	THE NEWMAN GROUP, LLC 42 SHERWOOD TERRACE SUITE 2 LAKE BLUFF, IL 60044 US Other 510(k) Applications for this Company
Contact	SPENCER NEWMAN 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	02/23/2009
Decision Date	04/08/2009
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	Y
Expedited Review