The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Allura Xper Fd10.
| Device ID | K041949 |
| 510k Number | K041949 |
| Device Name: | ALLURA XPER FD10 |
| Classification | System, X-ray, Angiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. VEENPLUIS 4-6- 5684 PC BEST The Netherlands, NL |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. VEENPLUIS 4-6- 5684 PC BEST The Netherlands, NL |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-20 |
| Decision Date | 2004-07-30 |
| Summary: | summary |