The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Phillips Omnidiagnost Eleva.
| Device ID | K032046 |
| 510k Number | K032046 |
| Device Name: | PHILLIPS OMNIDIAGNOST ELEVA |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10.000 Da Best, NL 5680 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-02 |
| Decision Date | 2003-07-17 |
| Summary: | summary |