K141872 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, Inc. (Alexandria, US). The FDA issued a Cleared decision on November 21, 2014, 133 days after receiving the submission on July 11, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1540.
| 510(k) Number | K141872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2014 |
| Decision Date | November 21, 2014 |
| Days to Decision | 133 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 |