FDA 510(k) Application Details - K191948

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K191948
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Verathon Medical (Canada) ULC 2227 Douglas Road Burnaby V5C 5A9 CA Other 510(k) Applications for this Company
Contact	Haleh Ghassemi 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	07/22/2019
Decision Date	08/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review