K241882
- 510(k) number
- K241882
- Device name
- Fetal & Maternal Monitor (F15A, F15A Air)
- Applicant
- Edan Instruments, Inc. CN
- Product code
- HGM — System, Monitoring, Perinatal
- Decision date
- 2025-08-27
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K241882.pdf
Official FDA record: K241882
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.