FDA 510(k) Application Details - K232603

Device Classification Name	More FDA Info for this Device
510(K) Number	K232603
Device Name	CamAPS FX
Applicant	CamDiab Ltd. 20-22 Wenlock Road London N1 7GU GB Other 510(k) Applications for this Company
Contact	Roman Hovorka Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2023
Decision Date	05/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review