K100233 is an FDA 510(k) clearance for the SUDOSCAN. This device is classified as a Device, Galvanic Skin Response Measurement (Class II - Special Controls, product code GZO).
Submitted by Impeto Medical (San Diego, US). The FDA issued a Cleared decision on June 14, 2010, 139 days after receiving the submission on January 26, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1540.
| 510(k) Number | K100233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2010 |
| Decision Date | June 14, 2010 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| 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 |