K131568 is an FDA 510(k) clearance for the SUDO PATH. This device is classified as a Device, Galvanic Skin Response Measurement (Class II - Special Controls, product code GZO).
Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on June 28, 2013, 29 days after receiving the submission on May 30, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1540.
| 510(k) Number | K131568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2013 |
| Decision Date | June 28, 2013 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZO - Device, Galvanic Skin Response Measurement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1540 |