The following data is part of a premarket notification filed by General Electric Co. with the FDA for L/u Arm - Neuro - Vascular #b5080b.
| Device ID | K791830 |
| 510k Number | K791830 |
| Device Name: | L/U ARM - NEURO - VASCULAR #B5080B |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | GENERAL ELECTRIC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-17 |
| Decision Date | 1979-10-26 |