K231667
- 510(k) number
- K231667
- Device name
- Withings Sleep Rx
- Applicant
- Withings FR
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2024-09-06
- Date received
- 2023-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231667.pdf
Official FDA record: K231667
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.