The following data is part of a premarket notification filed by Philips Medical Systems Netherland, B.v. with the FDA for Allura Xper Fd Series / Allura Xper Or Table Series.
| Device ID | K141979 |
| 510k Number | K141979 |
| Device Name: | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. VEENPLUIS 4-6 5684-PC Best, NL Netherland |
| Contact | Jeanette Becker |
| Correspondent | Jeanette Becker PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. VEENPLUIS 4-6 5684-PC Best, NL Netherland |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-21 |
| Decision Date | 2014-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838059122 | K141979 | 000 |
| 00884838054196 | K141979 | 000 |
| 00884838054202 | K141979 | 000 |
| 00884838054219 | K141979 | 000 |
| 00884838054226 | K141979 | 000 |
| 00884838054233 | K141979 | 000 |
| 00884838054240 | K141979 | 000 |
| 00884838054257 | K141979 | 000 |
| 00884838054264 | K141979 | 000 |
| 00884838054271 | K141979 | 000 |
| 00884838059115 | K141979 | 000 |
| 00884838054189 | K141979 | 000 |