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510(k) K232089

SOZO Pro by ImpediMed Limited — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2023
Date Received
July 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

Other clearances by ImpediMed Limited

  • K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (January 28, 2026)
  • K230531 — SOZO Pro (May 4, 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 DSB

  • K250634 — BCM2-Body Composition Monitor (November 24, 2025)
  • K243727 — Re:Balans (October 16, 2025)
  • K250922 — Edema Guard Monitor (EGM) CardioSet-001 (September 9, 2025)
  • K223217 — Zynex Monitoring System, Model CM-1600 (June 16, 2023)
  • K211585 — Bodyport Cardiac Scale (July 29, 2022)
  • K203473 — SOZO (April 19, 2021)
  • K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
  • K191697 — Cardiac Monitor 1500 (February 21, 2020)
  • K180479 — ReDS System (February 28, 2019)
  • K172431 — Cardiovascular Analzyer (March 14, 2018)