FDA 510(k) Application Details - K231536

Device Classification Name	More FDA Info for this Device
510(K) Number	K231536
Device Name	eQUANT System
Applicant	Avails Medical, Inc. 1455 Adams Dr. Ste 1288 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Meike Herget Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2023
Decision Date	02/08/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review