K231780
- 510(k) number
- K231780
- Device name
- Perifit Care+
- Applicant
- X6 Innovations FR
- Product code
- HIR — Perineometer
- Decision date
- 2023-12-20
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K231780.pdf
Official FDA record: K231780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.