Anesthesiology
RX-1 Sleep
Vivaquant, Inc. Dba Rhythm Express
FDA
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K253148
- Decision date
- June 2026
- FDA panel
- Anesthesiology
- Product code
- MNR
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K253148
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.