K260270

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

510(k) number
K260270
Device name
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
Applicant
FindAir Sp. z o.o. PL
Product code
CAF — Nebulizer (Direct Patient Interface)
Decision date
2026-06-02
Date received
2026-01-28
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K260270.pdf

Official FDA record: K260270
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.