K192890 is an FDA 510(k) clearance for the SentEP. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Sentiar, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 18, 2020, 344 days after receiving the submission on October 10, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K192890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2019 |
| Decision Date | September 18, 2020 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |