RI Witness Embryology Heated Plate
FDA 510(k) K160504 · Research Instruments Limited
510(k) numberK160504
Submission
- Device name
- RI Witness Embryology Heated Plate
- Applicant
- Research Instruments Limited
Falmouth, GB - Received
- February 24, 2016
- Decision date
- July 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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Questions and answers
When was RI Witness Embryology Heated Plate cleared by the FDA?
RI Witness Embryology Heated Plate (K160504) received a 510(k) decision of Substantially Equivalent on July 18, 2016, 145 days after the submission was received.
What is the product code of K160504?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.