The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Kodex Epd System.
| Device ID | K180940 |
| 510k Number | K180940 |
| Device Name: | KODEX EPD System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4, -6 Pc Best, NL 5684 |
| Contact | Gina Crossetta |
| Correspondent | Gina Crossetta Philips Medical Systems Nederland B.V. Veenpluis 4, -6 Pc Best, NL 5684 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-10 |
| Decision Date | 2018-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838095229 | K180940 | 000 |