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510(k) K190529

SOZO by ImpediMed Limited — Product Code QJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2019
Date Received
March 4, 2019
Clearance Type
Traditional
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

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  • K230530 — SOZO Pro (May 4, 2023)
  • K230531 — SOZO Pro (May 4, 2023)
  • K203473 — SOZO (April 19, 2021)
  • K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
  • 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

  • K230531 — SOZO Pro (May 4, 2023)