FDA 510(k) Application Details - K192427

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K192427
Device Name	System, X-Ray, Tomography, Computed
Applicant	NeuWave Medical, Inc. 3529 Anderson Street Madison, WI 53704 US Other 510(k) Applications for this Company
Contact	Neda Chini Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2019
Decision Date	10/03/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review