MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)— 510(k) K260224

Name: FDA 510(k) clearance K260224
Creator: U.S. Food and Drug Administration
Published: 2026-08-17

Substantially Equivalent

ImpediMed Limited

FDA 510(k) clearance K260224 for MySOZO Software version 6.1.0.1 (SW version 6.1.0.1), Substantially Equivalent on 2026-08-17. Applicant: ImpediMed Limited. Device class: 2.

Clearance details

Applicant: ImpediMed Limited
Product code: Code DSB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2026-01-26
Decision date: 2026-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lindfield, AU

Download summary PDF View on FDA.gov ↗

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More clearances from ImpediMed Limited

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K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)2026-01-28
K230530 — SOZO Pro2023-05-04
K230531 — SOZO Pro2023-05-04
K203473 — SOZO2021-04-19
K193410 — SOZO Body Fluid Analyzer2020-10-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.