K200944 is an FDA 510(k) clearance for the UNIEXPERT 2 PLUS. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Adani (Minsk, BY). The FDA issued a Cleared decision on May 26, 2020, 48 days after receiving the submission on April 8, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K200944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2020 |
| Decision Date | May 26, 2020 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |