Cleared Traditional

EmbryoScope+

K173264 · Vitrolife A/S · Obstetrics & Gynecology
May 2018
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K173264 is an FDA 510(k) clearance for the EmbryoScope+, a Accessory, Assisted Reproduction (Class II — Special Controls, product code MQG), submitted by Vitrolife A/S (Viby J, DK). The FDA issued a Cleared decision on May 11, 2018, 212 days after receiving the submission on October 11, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6120.

Submission Details

510(k) Number K173264 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2017
Decision Date May 11, 2018
Days to Decision 212 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQG — Accessory, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6120

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