FDA 510(k) Application Details - K201513

Device Classification Name	More FDA Info for this Device
510(K) Number	K201513
Device Name	Quantra QPlus System
Applicant	HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville, VA 22903 US Other 510(k) Applications for this Company
Contact	Anne Zavertnik Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2020
Decision Date	08/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review