510(k) K213345 ยท EWO Audiometer
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
| Applicant | Path Medical GmbH, Germering, DE |
| Decision | Substantially Equivalent, Jun 22, 2022 |
| Received | Oct 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2023 | PATH SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098 Open, Classified |
EWO | None listed |
| Nov 25, 2023 | PATH SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2 Open, Classified |
EWO | None listed |
| Nov 25, 2023 | PATH AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP Open, Classified |
EWO | None listed |
| Nov 25, 2023 | PATH SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S Open, Classified |
EWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.