FDA 510(k) Application Details - DEN220041

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220041
Device Name	Tristel Duo ULT
Applicant	Tristel Solutions Limited Unit 1B, Lynx Business Park, Fordham Road, Snailwell 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	06/29/2022
Decision Date	06/02/2023
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review