The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Advantx Lcv+.
| Device ID | K960575 |
| 510k Number | K960575 |
| Device Name: | ADVANTX LCV+ |
| Classification | System, X-ray, Angiographic |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger, Ph.d. |
| Correspondent | Larry A Kroger, Ph.d. GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1996-05-07 |
| Summary: | summary |