K231645
- 510(k) number
- K231645
- Device name
- PherDal® At-Home Insemination Kit
- Applicant
- Pherdal Fertility Science, Inc. IL · US
- Product code
- QYZ — At Home Intravaginal Insemination System
- Decision date
- 2023-12-14
- Date received
- 2023-06-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231645.pdf
Official FDA record: K231645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.