FDA 510(k) Application Details - K240075

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K240075
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Fujifilm Healthcare Americas Corporation 81 Hartwell Ave Suite 300 Lexington, MA 02421 US Other 510(k) Applications for this Company
Contact	Chaitrali Kulkarni 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	01/10/2024
Decision Date	02/07/2024
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