FDA 510(k) Application Details - K101952

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K101952
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 88 MCFAUL WAY P.O. BOX 10321 ZEPHYR COVE, NV 89448 US Other 510(k) Applications for this Company
Contact	MICHAEL SCOTT 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	07/12/2010
Decision Date	05/27/2011
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