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FDA 510(k)

EMBRYOSCOPE AND EMBRYOSLIDE

K-Number: K092183 · 2011-01-11

ApplicantUnisense Fertilitech A/S
Decision Date2011-01-11
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EMBRYOSCOPE AND EMBRYOSLIDE is the device name listed in this FDA 510(k) record. The listed applicant is Unisense Fertilitech A/S. It received FDA 510(k) clearance on 2011-01-11 under 510(k) number K092183. 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 AND EMBRYOSLIDE?

EMBRYOSCOPE AND EMBRYOSLIDE is a medical device that received FDA 510(k) clearance on 2011-01-11. The listed applicant is Unisense Fertilitech A/S. The 510(k) number is K092183.

When did EMBRYOSCOPE AND EMBRYOSLIDE receive FDA 510(k) clearance?

EMBRYOSCOPE AND EMBRYOSLIDE received FDA 510(k) clearance on 2011-01-11, under 510(k) number K092183.

Who is the listed applicant for EMBRYOSCOPE AND EMBRYOSLIDE?

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

What is the FDA product code for EMBRYOSCOPE AND EMBRYOSLIDE?

The FDA product code for EMBRYOSCOPE AND EMBRYOSLIDE is MQG.

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Other records listing Unisense Fertilitech 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.

K113075EMBRYO VIEWER SOFTWAREK111715EMBRYOSCOPE

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.

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)CooperSurgical, Inc.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.K173264EmbryoScope+Vitrolife A/S

Official Source

View on FDA Database →

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

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