FDA 510(k) Application Details - K212616

Device Classification Name	More FDA Info for this Device
510(K) Number	K212616
Device Name	Koios DS
Applicant	Koios Medical, Inc. 242 West 38th Street, 14th Floor New York, NY 10018 US Other 510(k) Applications for this Company
Contact	Patricia Setti-Laperch 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	08/18/2021
Decision Date	12/16/2021
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