SOZO
ImpediMed Limited is listed for SOZO (K180126). The FDA list gives April 16, 2018 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OBH as “Monitor, Extracellular Fluid, Lymphedema, Extremity”: 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) openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180126
- Date of final decision
- April 16, 2018
- Company on the FDA list
- ImpediMed Limited
- Lead panel
- Cardiovascular
- Primary product code
- OBH
- openFDA device name for the code
- Monitor, Extracellular Fluid, Lymphedema, Extremity
- Device class
- 2
- Regulation number
- 870.2770
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary
Product-code text from openFDA
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)