The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Artis Zee / Zeegos With Sw Vc14.
| Device ID | K090745 |
| 510k Number | K090745 |
| Device Name: | ARTIS ZEE / ZEEGOS WITH SW VC14 |
| Classification | System, X-ray, Angiographic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
| Contact | Gary Johnson |
| Correspondent | Gary Johnson SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY, E-50 Malvern, PA 19355 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-06-18 |
| Summary: | summary |