FDA 510(k) Application Details - K200163

Device Classification Name	Device, Fertility Diagnostic, Proceptive   More FDA Info for this Device
510(K) Number	K200163
Device Name	Device, Fertility Diagnostic, Proceptive
Applicant	Ava AG Gustrasse 73 Zurich 8055 CH Other 510(k) Applications for this Company
Contact	Blathnaid Feldman Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2020
Decision Date	01/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review