FDA 510(k) Application Details - K211064

Device Classification Name	More FDA Info for this Device
510(K) Number	K211064
Device Name	nView s1 with nav option
Applicant	nView medical 2681 E Parleys Way STE 107 Salt Lake City, UT 84109 US Other 510(k) Applications for this Company
Contact	Lisa Last Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2021
Decision Date	10/29/2021
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