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FDA 510(k)

EmbryoScope+

K-Number: K173264 · 2018-05-11

ApplicantVitrolife A/S
Decision Date2018-05-11
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EmbryoScope+ is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife A/S. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K173264. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmbryoScope+?

EmbryoScope+ is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Vitrolife A/S. The 510(k) number is K173264.

When did EmbryoScope+ receive FDA 510(k) clearance?

EmbryoScope+ received FDA 510(k) clearance on 2018-05-11, under 510(k) number K173264.

Who is the listed applicant for EmbryoScope+?

The FDA 510(k) record lists Vitrolife A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EmbryoScope+?

The FDA product code for EmbryoScope+ is MQG.

Other records listing Vitrolife A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213869EmbryoSlide+ ic8 dishK182798KIDScore D3

Related Devices (Code: MQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260194Vacuum Pump (Model: AD-VPUM-500)Sheng Sheng Yi (Beijing) Technology Company LimitedK242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.K180304Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.K171736Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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