SOZO
ImpediMed Limited is listed for SOZO (K190529). The FDA list gives November 25, 2019 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 QJB as “Adjunct Monitor, Protein Calorie Malnutrition”: Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters. 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=K190529
- Date of final decision
- November 25, 2019
- Company on the FDA list
- ImpediMed Limited
- Lead panel
- Cardiovascular
- Primary product code
- QJB
- openFDA device name for the code
- Adjunct Monitor, Protein Calorie Malnutrition
- 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
Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.