FDA 510(k) Application Details - K213423

Device Classification Name	More FDA Info for this Device
510(K) Number	K213423
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	Tim Hanson 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	10/20/2021
Decision Date	01/06/2023
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