FDA 510(k) Application Details - K201555

Device Classification Name	More FDA Info for this Device
510(K) Number	K201555
Device Name	EchoGo Pro
Applicant	Ultromics Ltd 4630 Kingsgate, Cascade Way, Oxford Business Park South Oxford OX4 2SU GB Other 510(k) Applications for this Company
Contact	Melissa Clark Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2020
Decision Date	12/18/2020
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