Embryoscope

FDA 510(k) K111715 · Unisense Fertilitech A/S

Substantially Equivalent

510(k) numberK111715

Submission

Device name
Embryoscope
Applicant
Unisense Fertilitech A/S
Arrhus N, DK
Received
June 20, 2011
Decision date
August 11, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQG – Accessory, Assisted Reproduction
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6120
Specialty
Obstetrics/Gynecology

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K173264EmbryoScope+MQG · Traditional Vitrolife A/S05/11/2018SE
K180304Geri Embryo Incubator and Geri DishMQG · Special Genea Biomedx Pty, Ltd.04/20/2018SE
K171736Geri Embryo Incubator and Geri DishMQG · Traditional Genea Biomedx Pty, Ltd.11/15/2017SE
K160753COOK Vacuum PumpMQG · Traditional William A. Cook Australia Pty. , Ltd.06/13/2017SE
K160504RI Witness Embryology Heated PlateMQG · Traditional Research Instruments Limited07/18/2016SE

More from Research Instruments Limited

510(k)DeviceDecision
K133712Embryoviewer SoftwareMQG · Traditional 08/08/2014SE
K113075Embryo Viewer SoftwareMQG · Traditional 12/21/2011SE
K092183Embryoscope and EmbryoslideMQG · Traditional 01/11/2011SE

Questions and answers

When was Embryoscope cleared by the FDA?

Embryoscope (K111715) received a 510(k) decision of Substantially Equivalent on August 11, 2011, 52 days after the submission was received.

What is the product code of K111715?

The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.