The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Allura Xper Or Table Series.
| Device ID | K102005 |
| 510k Number | K102005 |
| Device Name: | ALLURA XPER OR TABLE SERIES |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-08-09 |
| Summary: | summary |