FDA 510(k) Application Details - K230842

Device Classification Name	More FDA Info for this Device
510(K) Number	K230842
Device Name	SignalHF (IM008)
Applicant	Implicity Inc. 185 Alewife Brook Parkway Suite 210 Cambridge, MA 02138 US Other 510(k) Applications for this Company
Contact	Caroline Florequin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2023
Decision Date	10/25/2023
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