FDA 510(k) Application Details - K092637

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K092637
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	SONOMED, INC. 1979 MARCUS AVE. SUITE 105C LAKE SUCCESS, NY 11040 US Other 510(k) Applications for this Company
Contact	CHARLES C O'NEAL 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	08/27/2009
Decision Date	09/24/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review