FDA 510(k) Application Details - K192523

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K192523
Device Name	Esophagoscope (Flexible Or Rigid)
Applicant	Karl Storz SE & Co. KG Dr.-Karl-Storz-StraBe 34 Tuttlingen 78532 DE Other 510(k) Applications for this Company
Contact	Alexey Davidov Other 510(k) Applications for this Contact
Regulation Number	874.4710   More FDA Info for this Regulation Number
Classification Product Code	EOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2019
Decision Date	01/24/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review