K182112 is an FDA 510(k) clearance for the Sense System with IBT Electrodes. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Infinite Biomedical Technologies, LLC (Baltimore, US). The FDA issued a Cleared decision on October 5, 2018, 60 days after receiving the submission on August 6, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K182112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2018 |
| Decision Date | October 05, 2018 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |