K251480
- 510(k) number
- K251480
- Device name
- PV01 PVDF Effort Sensor
- Applicant
- Neurotronics, LLC FL · US
- Product code
- SFK — Respiratory Effort Belt For Polysomnography
- Decision date
- 2025-08-29
- Date received
- 2025-05-13
- 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: K251480.pdf
Official FDA record: K251480
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.