← Product Code [DSB](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB) · K823215

# CKG 8800 (K823215)

_Cardio Kinetics, Inc. · DSB · Nov 24, 1982 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K823215

## Device Facts

- **Applicant:** Cardio Kinetics, Inc.
- **Product Code:** [DSB](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB.md)
- **Decision Date:** Nov 24, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2770
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K823215](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSB/K823215)

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