Miri TL
FDA 510(k) K151357 · At Medical Uab
510(k) numberK151357
Submission
- Device name
- Miri TL
- Applicant
- At Medical Uab
Kaunas, LT - Received
- May 20, 2015
- Decision date
- April 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K180304 | Geri Embryo Incubator and Geri DishMQG · Special | Genea Biomedx Pty, Ltd. | 04/20/2018SE |
| K171736 | Geri Embryo Incubator and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 11/15/2017SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
| K160504 | RI Witness Embryology Heated PlateMQG · Traditional | Research Instruments Limited | 07/18/2016SE |
More from Research Instruments Limited
| 510(k) | Device | Decision |
|---|---|---|
| K133742 | XQ-1 IncubatorMQG · Traditional | 04/23/2014SE |
Questions and answers
When was Miri TL cleared by the FDA?
Miri TL (K151357) received a 510(k) decision of Substantially Equivalent on April 22, 2016, 338 days after the submission was received.
What is the product code of K151357?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.