FDA 510(k) Application Details - K231818

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K231818
Device Name	Bronchoscope Accessory
Applicant	M/s Meril Life Sciences Pvt. Ltd. Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi Vapi 396191 IN Other 510(k) Applications for this Company
Contact	Umesh Sharma 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	06/21/2023
Decision Date	11/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review