K131141 is an FDA 510(k) clearance for the EARPROBE. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).
Submitted by Path Medical GmbH (Germering, Bavaria, DE). The FDA issued a Cleared decision on June 27, 2013, 65 days after receiving the submission on April 23, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K131141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2013 |
| Decision Date | June 27, 2013 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWJ - Stimulator, Auditory, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1900 |