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 Series; Allura Xper Fd10 Series; Allura Xper Fd20 Series; Allura Xper Fd Biplane Series.
| Device ID | K130842 |
| 510k Number | K130842 |
| Device Name: | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES |
| Classification | System, X-ray, Angiographic |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Jos Van Vroonhoven |
| Correspondent | J.a. Van Vugt DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-03-27 |
| Decision Date | 2013-05-21 |
| Summary: | summary |