SOZO Pro— 510(k) K230531

Substantially Equivalent

ImpediMed Limited

FDA 510(k) clearance K230531 for SOZO Pro, Substantially Equivalent on 2023-05-04. Applicant: ImpediMed Limited. Device class: 2.

Clearance details

Applicant: ImpediMed Limited
Product code: Code QJB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2023-02-27
Decision date: 2023-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Pinkenba, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJB

K190529 — SOZO2019-11-25

More clearances from ImpediMed Limited

K260224 — MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)2026-08-17
K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)2026-01-28
K232089 — SOZO Pro2023-10-17
K230530 — SOZO Pro2023-05-04
K203473 — SOZO2021-04-19

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