510(k) K200944
K200944 is an FDA 510(k) premarket notification submitted by Adani for the device "UNIEXPERT 2 PLUS". The FDA issued a decision of Substantially Equivalent on May 26, 2020. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Adani has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2020
- Date Received
- Apr 8, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)