MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)— 510(k) K253224

Substantially Equivalent

ImpediMed Limited

FDA 510(k) clearance K253224 for MySOZO Software version 6.0.1.2 (SW version 6.0.1.2), Substantially Equivalent on 2026-01-28. Applicant: ImpediMed Limited.

Clearance details

Applicant: ImpediMed Limited
Product code: Code OBH
Advisory panel: Cardiovascular
Date received: 2025-09-29
Decision date: 2026-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinkenba, AU

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