FDA 510(k) Application Details - K250106

Device Classification Name	More FDA Info for this Device
510(K) Number	K250106
Device Name	Signos Glucose Monitoring System
Applicant	Signos, Inc. 30011 Ivy Glenn Drive Suite 107 Laguna Niguel, CA 92677 US Other 510(k) Applications for this Company
Contact	Trevor Denbo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2025
Decision Date	03/21/2025
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