FDA 510(k) Application Details - K200965

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K200965
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	KARL STORZ Endoscopy America, Inc. 2151 E Grand Ave El Segundo, CA 90245 US Other 510(k) Applications for this Company
Contact	Winkie Wong Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2020
Decision Date	12/29/2020
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