S-Line— 510(k) K213191
Substantially EquivalentBarkey GmbH & Co. KG
FDA 510(k) clearance K213191 for S-Line, Substantially Equivalent on 2022-05-24. Applicant: Barkey GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Barkey GmbH & Co. KG
- Product code
- Code LGZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leopoldshoehe, DE
Recent devices under product code LGZ
view allMore clearances from Barkey GmbH & Co. KG
view allAdverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.