The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Multidiagnost Eleva.
| Device ID | K023441 |
| 510k Number | K023441 |
| Device Name: | PHILIPS MULTIDIAGNOST ELEVA |
| Classification | System, X-ray, Angiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS 4-6 VEENPLUIS, P.O. BOX 1000 Best, NL 5680 Da |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2002-10-30 |
| Summary: | summary |