K834583 is an FDA 510(k) clearance for the CLEAR LEADS-RADIOTRANSPARENT WIRES. This device is classified as a Cable, Electrode (Class II - Special Controls, product code IKD).
Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984, 32 days after receiving the submission on December 29, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1175.
| 510(k) Number | K834583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1983 |
| Decision Date | January 30, 1984 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IKD — Cable, Electrode |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1175 |