The following data is part of a premarket notification filed by Path Medical Gmbh with the FDA for Sentiero, Audx, Audx Pro, Sentiero Desktop, Audx Pro Flex, Sentiero Advanced, Navpro One.
| Device ID | K213345 |
| 510k Number | K213345 |
| Device Name: | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE |
| Classification | Audiometer |
| Applicant | Path Medical GmbH Landsberger Strasse 65 Germering, DE 82110 |
| Contact | Johann Oswald |
| Correspondent | Johann Oswald Path Medical GmbH Landsberger Strasse 65 Germering, DE 82110 |
| Product Code | EWO |
| Subsequent Product Code | ETY |
| Subsequent Product Code | GWJ |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-08 |
| Decision Date | 2022-06-22 |