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.
Clearance details
- Applicant
- Vivaquant, Inc. Dba Rhythm Express
- Product code
- 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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