FDA 510(k) Application Details - K241679

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K241679
Device Name	Bronchoscope Accessory
Applicant	Alton (Shanghai) Medical Instruments Co. Ltd No.24 Building Jinshao Rd.1688.Baoshan District Shanghai 200949 CN Other 510(k) Applications for this Company
Contact	Vivian Li 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	06/11/2024
Decision Date	03/04/2025
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