FDA · official record K260270Substantially Equivalent

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

Name: FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) — FDA K260270
Creator: FindAir Sp. z o.o.
Keywords: FindAir ONE for pMDI (FAO-MDI-V12-GRE-001), FindAir ONE for pMDI (FAO-MDI-V12-GRE-001), K260270, CAF, FDA

United StatesCAFFindAir Sp. z o.o.

Verified

Official record identity

FDA application number: K260270
Decision date: June 02, 2026
Published decision: Substantially Equivalent

Classification

Product code: CAF

Published parties

Applicant: FindAir Sp. z o.o.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2026-01-28
Review panel: Anesthesiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 868.5630

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.