FDA 510(k) Application Details - K170338

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K170338
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	Stroke2Prevent B.V. Dokter Stolteweg 70 8025 AZ Zwolle 8025 NL Other 510(k) Applications for this Company
Contact	Maarten Nibbelke 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	02/02/2017
Decision Date	05/16/2017
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