FDA 510(k) Application Details - K213869

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K213869
Device Name	Labware, Assisted Reproduction
Applicant	Vitrolife A/S Jens Juuls Vej 20 Viby J 8260 DK Other 510(k) Applications for this Company
Contact	Belinda Dueholm Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2021
Decision Date	03/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review