K230780
- 510(k) number
- K230780
- Device name
- MFG-05
- Applicant
- Zimmer Medizinsysteme GmbH DE
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2023-10-05
- Date received
- 2023-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230780.pdf
Official FDA record: K230780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.