RX-1 Sleep— 510(k) K253148

Substantially Equivalent

Vivaquant, 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.

Clearance details

Applicant
Vivaquant, Inc. Dba Rhythm Express
Product code
Code MNR
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arden Hills, MN, US
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