SENTIERO— 510(k) K133012
Substantially EquivalentPath Medical GmbH
FDA 510(k) clearance K133012 for SENTIERO, Substantially Equivalent on 2014-06-09. 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, Bavaria, 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 K133012
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 K133012.
Data sourced from openFDA. This site is unofficial and independent of the FDA.