K254104

ResScan Essentials

510(k) number
K254104
Device name
ResScan Essentials
Applicant
Resmed Corp CA · US
Product code
BZD — Ventilator, Non-Continuous (Respirator)
Decision date
2026-05-27
Date received
2025-12-19
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Anesthesiology
510(k) Summary (official FDA PDF): K254104.pdf
Official FDA record: K254104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.