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510(k) K143310

MoisturemeterD by Delfin Technologies, Ltd. — Product Code OBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2015
Date Received
November 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type

Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)

Other clearances by Delfin Technologies, Ltd.

  • K220557 — MoistureMeterD Compact, LymphScanner (May 27, 2022)

Other clearances for product code OBH

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  • K230530 — SOZO Pro (May 4, 2023)
  • K220557 — MoistureMeterD Compact, LymphScanner (May 27, 2022)
  • K180126 — SOZO (April 16, 2018)
  • K172122 — SOZO (August 11, 2017)
  • K130338 — IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (May 31, 2013)
  • K100811 — IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (November 4, 2011)
  • K080825 — IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (October 3, 2008)
  • K050415 — IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (March 30, 2007)