FDA 510(k) Application Details - K212361

Device Classification Name	More FDA Info for this Device
510(K) Number	K212361
Device Name	Novo
Applicant	PathAI, INC. 1325 Boylston Avenue Suite 10000 Boston, MA 02215 US Other 510(k) Applications for this Company
Contact	Kathy Wack 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	07/30/2021
Decision Date	08/11/2022
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