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) → QAF — Impedance Plethysmograph, Cranial

# QAF · Impedance Plethysmograph, Cranial

_Cardiovascular · 21 CFR 870.2770 · Class 2_

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

## Overview

- **Product Code:** QAF
- **Device Name:** Impedance Plethysmograph, Cranial
- **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 |
| --- | --- | --- | --- | --- |
| [K182967](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QAF/K182967.md) | Visor System | Cerebrotech Medical Systems, Inc. | Nov 23, 2018 | SESE |
| [K171186](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/QAF/K171186.md) | Cerebrotech CMS-5000 | Cerebrotech Medical Systems | Dec 8, 2017 | SESE |

## Top Applicants

- Cerebrotech Medical Systems — 1 clearance
- Cerebrotech Medical Systems, Inc. — 1 clearance

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

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