FDA 510(k) Application Details - K182683

Device Classification Name	Couch, Radiation Therapy, Powered   More FDA Info for this Device
510(K) Number	K182683
Device Name	Couch, Radiation Therapy, Powered
Applicant	Chinan Biomedical Technology, Inc. 6F., No.16, Sec.2 , Shengyi Rd., Zhubei City Hsinchu County 302 TW Other 510(k) Applications for this Company
Contact	James Chinan Chen Other 510(k) Applications for this Contact
Regulation Number	892.5770   More FDA Info for this Regulation Number
Classification Product Code	JAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2018
Decision Date	06/27/2019
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