FDA 510(k) Application Details - K250414

Device Classification Name	More FDA Info for this Device
510(K) Number	K250414
Device Name	CaloPix
Applicant	Tribun Health 30 Boulevard de Vaugirard Paris 75015 FR Other 510(k) Applications for this Company
Contact	Jean-Franτois Pomerol Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2025
Decision Date	05/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review