The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Orthopaedic Applications.
| Device ID | K042867 |
| 510k Number | K042867 |
| Device Name: | PHILIPS ORTHOPAEDIC APPLICATIONS |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Contact | Lynn T Harmer |
| Correspondent | Melissa J Deguia UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2004-11-02 |
| Summary: | summary |