The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Allura Xper Fd; Or Table.
| Device ID | K133292 |
| 510k Number | K133292 |
| Device Name: | ALLURA XPER FD; OR TABLE |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Klien Van Dam |
| Correspondent | Klien Van Dam PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-03-05 |
| Summary: | summary |