K180940 is an FDA 510(k) clearance for the KODEX EPD System. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Philips Medical Systems Nederland B.V. (Pc Best, NL). The FDA issued a Cleared decision on October 24, 2018, 197 days after receiving the submission on April 10, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K180940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2018 |
| Decision Date | October 24, 2018 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |