FDA 510(k) Application Details - K140199

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K140199
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	SONOMED, INC. 1979 MARCUS AVE., SUITE 105C LAKE SUCCESS, NY 11042 US Other 510(k) Applications for this Company
Contact	CHARLES C O'NEAL Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2014
Decision Date	04/01/2014
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	N
Expedited Review