Esco obtains the FDA 510(k) on the Miri®


Apr 27, 2014

Esco obtains the FDA 510(k) on the Miri®

Cheers to Esco Medical for receiving the FDA 510(k) clearance on the Miri® benchtop incubator!  Another success due to Esco’s efforts in upholding its promise of delivering reliable equipment.  Through FDA 510(k), it is guaranteed that Miri® Multi-room Incubator provides a safe and controlled environment for the development of gametes and embryos during in vitro fertilization or assisted reproduction technology (ART) treatments.

To equip IVF laboratories and clinics and provide the best standards of care, Miri® boasts a unique set of features that cannot be found elsewhere.

• Mixed gas NOT required = reduced operating costs
• Heating in the lid (oil overlay not required)
• Documented UVC decontamination of recirculated gas
• MEA tested and documented
• 12 x PID regulation system, the most advanced in the world
• Built-in temperature validation
• Full parameter display at a distance
• Pressure sensors on external gas

All in all, the Esco Miri Multi-Room CO2 Incubator is the perfect choice for routine embryo culture for any IVF clinic.

 The 510(k) Clearances of the Food, Drug and Cosmetic Act required device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.  This is also known as Premarket Notification – also called as PMN.  This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.  Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time of reintroduce a device into  significantly changes or modified to the extent that its safety or effectiveness could be affected.

Source: US Food and Drug Administration, Department of Health and Human Services