K100661 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 (Fort Collins, US). The FDA issued a Cleared decision on July 1, 2010, 115 days after receiving the submission on March 8, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.
| 510(k) Number | K100661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2010 |
| Decision Date | July 01, 2010 |
| Days to Decision | 115 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 |