K253148
- 510(k) number
- K253148
- Device name
- RX-1 Sleep
- Applicant
- Vivaquant, Inc. Dba Rhythm Express MN · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2026-06-22
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K253148.pdf
Official FDA record: K253148
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.