RX-1 Sleep— 510(k) K253148
Substantially EquivalentVivaquant, Inc. Dba Rhythm Express
FDA 510(k) clearance K253148 for RX-1 Sleep, Substantially Equivalent on 2026-06-22. Applicant: Vivaquant, Inc. Dba Rhythm Express. Device class: 2.
Summary
RX-1 Sleep is from Vivaquant, doing business as Rhythm Express, and is filed under MNR, ventilatory effort recorders. The record doesn't describe the device beyond its name and the code name.
Class II, 21 CFR 868.2375. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k).
Vivaquant filed from Arden Hills, Minnesota. Review took 270 calendar days (September 25, 2025 to June 22, 2026).
Clearance details
- Applicant
- Vivaquant, Inc. Dba Rhythm Express
- Product code
- Product code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arden Hills, MN, US
Recent devices under product code MNR
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