K241009
- 510(k) number
- K241009
- Device name
- PeriCALM Patterns 3.0
- Applicant
- Perigen, Inc. IL
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2025-01-10
- Date received
- 2024-04-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K241009.pdf
Official FDA record: K241009
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.