FDA 510(k) Application Details - K100204

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K100204
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	SMITH ASSOCIATES 1676 VILLAGE GREEN, SUITE A CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E J SMITH 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	01/25/2010
Decision Date	02/19/2010
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