K213345 is an FDA 510(k) clearance for the Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Path Medical GmbH (Germering, DE). The FDA issued a Cleared decision on June 22, 2022, 257 days after receiving the submission on October 8, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K213345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2021 |
| Decision Date | June 22, 2022 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWO - Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |