FDA 510(k) Application Details - K202180

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K202180
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Axess Vision Technology Zone de la LiodiΦre 6, rue de la FlottiΦre JouΘ-lΦs-Tours 37300 FR Other 510(k) Applications for this Company
Contact	Marie-HΘlΦne Bacheley Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2020
Decision Date	10/22/2020
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	Y
Expedited Review