FDA 510(k) Application Details - K230545

Device Classification Name	More FDA Info for this Device
510(K) Number	K230545
Device Name	Inessa System
Applicant	Triple Jump Israel Ltd. 5 HaCarmel St., P.O.B. 205 Yokneam lllit 2069203 IL Other 510(k) Applications for this Company
Contact	Liron Hadar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2023
Decision Date	12/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review