K233440
- 510(k) number
- K233440
- Device name
- Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
- Applicant
- Philips Medizin Systeme Boeblingen GmbH DE
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2024-07-02
- Date received
- 2023-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233440.pdf
Official FDA record: K233440
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.