FDA 510(k)

MIRI TL

K-Number: K151357 · 2016-04-22

Decision Date2016-04-22

Product CodeMQG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

MIRI TL is the device name listed in this FDA 510(k) record. The listed applicant is At Medical Uab. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K151357. 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 MIRI TL?

MIRI TL is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is At Medical Uab. The 510(k) number is K151357.

When did MIRI TL receive FDA 510(k) clearance?

MIRI TL received FDA 510(k) clearance on 2016-04-22, under 510(k) number K151357.

Who is the listed applicant for MIRI TL?

The FDA 510(k) record lists At Medical Uab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIRI TL?

The FDA product code for MIRI TL is MQG.

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 Limited K242684Harioculture 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 K180304Geri 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.