FDA 510(k) Application Details - K242526

Device Classification Name	More FDA Info for this Device
510(K) Number	K242526
Device Name	Visby Medical Respiratory Health Test
Applicant	Visby Medical, Inc. 3010 North First Street San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Jennifer Albrecht Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2024
Decision Date	02/19/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review