Medical Device Manufacturer · US , San Diego , CA

ImpediMed Limited

12 submissions · 12 cleared · Since 2011
12
Total
12
Cleared
0
Denied

ImpediMed Limited — FDA 510(k) Submissions

ImpediMed Limited has submitted 12 FDA 510(k) premarket notifications since 2011, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Monitor, Extracellular Fluid, Lymphedema, Extremity, Plethysmograph, Impedance, Adjunct Monitor, Protein Calorie Malnutrition . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
K253224 · OBH Monitor, Extracellular... · Gastroenterology & Urology
Jan 2026 121d
SOZO Pro
K232089 · DSB Plethysmograph, Impedance · Gastroenterology & Urology
Oct 2023 96d
SOZO Pro
K230530 · OBH Monitor, Extracellular... · Gastroenterology & Urology
May 2023 66d
SOZO Pro
K230531 · QJB Adjunct Monitor, Protein... · Gastroenterology & Urology
May 2023 66d
SOZO
K203473 · DSB Plethysmograph, Impedance · Gastroenterology & Urology
Apr 2021 145d
SOZO Body Fluid Analyzer
K193410 · DSB Plethysmograph, Impedance · Gastroenterology & Urology
Oct 2020 298d
SOZO
K190529 · QJB Adjunct Monitor, Protein... · Gastroenterology & Urology
Nov 2019 266d
SOZO
K180126 · OBH Monitor, Extracellular... · Gastroenterology & Urology
Apr 2018 90d
SOZO
K172507 · DSB Plethysmograph, Impedance · Cardiovascular
Dec 2017 126d
SOZO
K172122 · OBH Monitor, Extracellular... · Gastroenterology & Urology
Aug 2017 29d
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
K130338 · OBH Monitor, Extracellular... · Gastroenterology & Urology
May 2013 109d
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
K100811 · OBH Monitor, Extracellular... · Gastroenterology & Urology
Nov 2011 592d
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