The following data is part of a premarket notification filed by General Electric Co. with the FDA for L/u Arm-vascular.
| Device ID | K781571 |
| 510k Number | K781571 |
| Device Name: | L/U ARM-VASCULAR |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | GENERAL ELECTRIC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-14 |
| Decision Date | 1978-11-27 |