K243513
- 510(k) number
- K243513
- Device name
- DCM (PW-DCM)
- Applicant
- Pneumowave, Ltd. GB
- Product code
- LEL — Device, Sleep Assessment
- Decision date
- 2025-04-16
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243513.pdf
Official FDA record: K243513
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.