Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770) → QJB — Adjunct Monitor, Protein Calorie Malnutrition

# QJB · Adjunct Monitor, Protein Calorie Malnutrition

_Cardiovascular · 21 CFR 870.2770 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QJB

## Overview

- **Product Code:** QJB
- **Device Name:** Adjunct Monitor, Protein Calorie Malnutrition
- **Regulation:** [21 CFR 870.2770](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2770)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QJB/K230531.md) | SOZO Pro | ImpediMed Limited | May 4, 2023 | SESE |
| [K190529](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QJB/K190529.md) | SOZO | ImpediMed Limited | Nov 25, 2019 | SESE |

## Top Applicants

- ImpediMed Limited — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QJB](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QJB)

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