510(k) K173264

EmbryoScope+ by Vitrolife A/S — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2018
Date Received
October 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type