FDA 510(k) Application Details - K242120

Device Classification Name	More FDA Info for this Device
510(K) Number	K242120
Device Name	OTOPLAN
Applicant	Cascination AG Steigerhubelstrasse 3 Bern 3008 CH Other 510(k) Applications for this Company
Contact	Gordana Salleles Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2024
Decision Date	04/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review