The following data is part of a premarket notification filed by General Electric Co. with the FDA for Lc, Cardiac Positioner #b5078a.
| Device ID | K890348 |
| 510k Number | K890348 |
| Device Name: | LC, CARDIAC POSITIONER #B5078A |
| Classification | System, X-ray, Angiographic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Kroger, Phd |
| Correspondent | Kroger, Phd GENERAL ELECTRIC CO. P.O. 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 | 1989-01-23 |
| Decision Date | 1989-02-27 |