Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE— 510(k) K213345
Substantially EquivalentPath Medical GmbH
FDA 510(k) clearance K213345 for Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE, Substantially Equivalent on 2022-06-22. Applicant: Path Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Path Medical GmbH
- Product code
- Code EWO
- Device class
- Class 2
- Regulation
- 21 CFR 874.1050
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Germering, DE
Recent devices under product code EWO
view allMore clearances from Path Medical GmbH
view allAdverse events under product code EWO
product code EWO- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K213345
K-number listed on FDA's recall record- Z-0401-2024 — SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
- Z-0402-2024 — SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
- Z-0403-2024 — AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
- Z-0404-2024 — SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213345.
Data sourced from openFDA. This site is unofficial and independent of the FDA.