510(k) K160504
K160504 is an FDA 510(k) premarket notification submitted by Research Instruments Limited for the device "RI Witness Embryology Heated Plate". The FDA issued a decision of Substantially Equivalent on July 18, 2016. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Research Instruments Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2016
- Date Received
- February 24, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type