FDA 510(k) Application Details - K191491

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K191491
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	MedXPress.Pro Slachthuislaan 1, bus 102 Leuven 3000 BE Other 510(k) Applications for this Company
Contact	Katherine Hughey 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	06/05/2019
Decision Date	06/05/2020
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