FDA 510(k) Application Details - K223578

Device Classification Name	More FDA Info for this Device
510(K) Number	K223578
Device Name	T3 Platform software
Applicant	Etiometry, Inc. 280 Summer St., 4th Floor Boston, MA 02210 US Other 510(k) Applications for this Company
Contact	Timothy Hanson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2022
Decision Date	07/07/2023
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