FDA 510(k) Application Details - K220854

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K220854
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	AW Technologies ApS Amalienborgvej 57 Noerresundby DK-9700 DK Other 510(k) Applications for this Company
Contact	Adam Hansen Other 510(k) Applications for this Contact
Regulation Number	868.5750   More FDA Info for this Regulation Number
Classification Product Code	BSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2022
Decision Date	04/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review