The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Clear Leads-radiotransparent Wires.
| Device ID | K834583 |
| 510k Number | K834583 |
| Device Name: | CLEAR LEADS-RADIOTRANSPARENT WIRES |
| Classification | Cable, Electrode |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IKD |
| CFR Regulation Number | 890.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-29 |
| Decision Date | 1984-01-30 |