The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Integris Allura.
| Device ID | K002016 |
| 510k Number | K002016 |
| Device Name: | PHILIPS INTEGRIS ALLURA |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL 5680 |
| Contact | Peter Altman |
| Correspondent | Peter Altman PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL 5680 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-09-06 |