FDA 510(k) Application Details - K250042

Device Classification Name	More FDA Info for this Device
510(K) Number	K250042
Device Name	PeekMed web
Applicant	Peek Health, S.A. Centro de Neg≤cios Ideia AtlΓntico, Rua Padres Carmelitas Braga 4719-005 PT Other 510(k) Applications for this Company
Contact	Sara Silva Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2025
Decision Date	03/19/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review