Product code QJB
- Device name
- Adjunct Monitor, Protein Calorie Malnutrition
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2770
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K230531 | SOZO Pro | ImpediMed Limited | 2023-05-04 |
| K190529 | SOZO | ImpediMed Limited | 2019-11-25 |