FDA 510(k) Application Details - K242642

Device Classification Name	Cuff, Tracheal Tube, Inflatable   More FDA Info for this Device
510(K) Number	K242642
Device Name	Cuff, Tracheal Tube, Inflatable
Applicant	Shanghai Longmann Tech Co., Ltd. Room 2106, No.3, Lane791 Lingling Road Shanghai 200030 CN Other 510(k) Applications for this Company
Contact	Yexue Gao 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	09/03/2024
Decision Date	03/07/2025
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