K070926 is an FDA 510(k) clearance for the ELECTRODE/EXTENSION CABLES, MODELS ATAR. This device is classified as a Cable, Electrode (Class II - Special Controls, product code IKD).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 7, 2007, 65 days after receiving the submission on April 3, 2007.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1175.
| 510(k) Number | K070926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2007 |
| Decision Date | June 07, 2007 |
| Days to Decision | 65 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IKD — Cable, Electrode |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1175 |