K242447
- 510(k) number
- K242447
- Device name
- Falcon HST
- Applicant
- Compumedics Limited AU
- Product code
- OLV — Standard Polysomnograph With Electroencephalograph
- Decision date
- 2025-02-20
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K242447.pdf
Official FDA record: K242447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.