QJB · Adjunct Monitor, Protein Calorie Malnutrition
Cardiovascular · 21 CFR 870.2770 · Class 2
Overview
| Product Code | QJB |
|---|---|
| Device Name | Adjunct Monitor, Protein Calorie Malnutrition |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.
Classification Rationale
Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230531 | SOZO Pro | ImpediMed Limited | May 4, 2023 | SESE |
| K190529 | SOZO | ImpediMed Limited | Nov 25, 2019 | SESE |
Top Applicants
- ImpediMed Limited — 2 clearances
