K240700
- 510(k) number
- K240700
- Device name
- HomeSleepTest (HST, HST REM+)
- Applicant
- Somnomedics GmbH DE
- Product code
- OLV — Standard Polysomnograph With Electroencephalograph
- Decision date
- 2024-12-08
- Date received
- 2024-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240700.pdf
Official FDA record: K240700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.