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510(k) K230531

SOZO Pro by ImpediMed Limited — Product Code QJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2023
Date Received
February 27, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunct Monitor, Protein Calorie Malnutrition
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type

Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.

Other clearances by ImpediMed Limited

  • K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (January 28, 2026)
  • K232089 — SOZO Pro (October 17, 2023)
  • K230530 — SOZO Pro (May 4, 2023)
  • K203473 — SOZO (April 19, 2021)
  • K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
  • K190529 — SOZO (November 25, 2019)
  • K180126 — SOZO (April 16, 2018)
  • K172507 — SOZO (December 22, 2017)
  • K172122 — SOZO (August 11, 2017)
  • K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (May 31, 2013)

Other clearances for product code QJB

  • K190529 — SOZO (November 25, 2019)