FDA 510(k) Application Details - K242732

Device Classification Name	More FDA Info for this Device
510(K) Number	K242732
Device Name	Tristel OPH
Applicant	Tristel Solutions Ltd. Unit 1b, Lynx Business Park, Fordham Road Snailwell Cambridgeshire CB8 7NY GB Other 510(k) Applications for this Company
Contact	Julija Shabanova Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/2024
Decision Date	05/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review