FDA 510(k) Application Details - K230778

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K230778
Device Name	Bronchoscope Accessory
Applicant	Praxis Medical, LLC 500 N Willow Ave. Ste 101 Tampa, FL 33606 US Other 510(k) Applications for this Company
Contact	John Fisher Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	KTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2023
Decision Date	09/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review