K152216 is an FDA 510(k) clearance for the SudoC. 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 September 24, 2015, 48 days after receiving the submission on August 7, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1540.
| 510(k) Number | K152216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2015 |
| Decision Date | September 24, 2015 |
| Days to Decision | 48 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 |