FDA 510(k) Application Details - K200760

Device Classification Name	More FDA Info for this Device
510(K) Number	K200760
Device Name	Rapid ASPECTS
Applicant	iSchemaView Inc. 433 Park Point Drive, Suite 220 Golden, CO 80401 US Other 510(k) Applications for this Company
Contact	Jim Rosa 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	03/24/2020
Decision Date	06/26/2020
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