K102166 is an FDA 510(k) clearance for the ELECTRO INTERSTITIAL SCAN. 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 December 10, 2010, 130 days after receiving the submission on August 2, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1540.
| 510(k) Number | K102166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2010 |
| Decision Date | December 10, 2010 |
| Days to Decision | 130 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 |