FDA 510(k) Application Details - K170741

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K170741
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	GEOTEK Medikal Ltd Sti Ivedik OSB, Agac Metal Sitesi 1436 Sk. No:12 Ankara 06738 TR Other 510(k) Applications for this Company
Contact	Latif Iba 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	03/10/2017
Decision Date	06/01/2017
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	N
Expedited Review