The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Philips Easydiagnost Eleva.
| Device ID | K031535 |
| 510k Number | K031535 |
| Device Name: | PHILIPS EASYDIAGNOST ELEVA |
| Classification | System, X-ray, Stationary |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98021 -3003 |
| Contact | Lynn T Harmer |
| Correspondent | Lynn T Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98021 -3003 |
| Product Code | KPR |
| Subsequent Product Code | IXL |
| Subsequent Product Code | IXR |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-06-17 |
| Summary: | summary |