The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Allura Xper Fd Series And Allura Xper Or Table Series.
| Device ID | K162859 |
| 510k Number | K162859 |
| Device Name: | Allura Xper FD Series And Allura Xper OR Table Series |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Jeanette Becker |
| Correspondent | Jeanette Becker Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-12 |
| Decision Date | 2016-12-02 |
| Summary: | summary |