FDA 510(k) Application Details - K240558

Device Classification Name	More FDA Info for this Device
510(K) Number	K240558
Device Name	NAVOYCDS
Applicant	AlgoDx AB PO Box 559173-7985, Visiting address: Gotgatan 22A Stockholm 106 31 SE Other 510(k) Applications for this Company
Contact	Andreas Macura Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2024
Decision Date	07/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review