The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Multidiagnost Eleva.
| Device ID | K050151 |
| 510k Number | K050151 |
| Device Name: | MULTIDIAGNOST ELEVA |
| Classification | System, X-ray, Stationary |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98021 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-02-09 |
| Summary: | summary |