Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2370](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2370) → KRC — Tester, Electrode, Surface, Electrocardiographic

# KRC · Tester, Electrode, Surface, Electrocardiographic

_Cardiovascular · 21 CFR 870.2370 · Class 2_

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

## Overview

- **Product Code:** KRC
- **Device Name:** Tester, Electrode, Surface, Electrocardiographic
- **Regulation:** [21 CFR 870.2370](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2370)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023713](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K023713.md) | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 | Sontra Medical, Inc. | Jan 28, 2004 | SESE |
| [K872370](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K872370.md) | BIOMA 3500 | E.B.S., Inc. | Dec 7, 1987 | SESE |
| [K874327](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K874327.md) | SKIN PREP ANALYZER | Marquette Electronics, Inc. | Nov 23, 1987 | SESE |
| [K874155](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K874155.md) | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | Circadian, Inc. | Nov 23, 1987 | SESE |
| [K840358](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K840358.md) | IMPEDANCE/8200 MONITOR-MODEL 8300 | Aequitron Medical, Inc. | Oct 30, 1984 | SESE |
| [K833619](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K833619.md) | CONDUCTANCE METER | Circadian, Inc. | Jan 27, 1984 | SESE |
| [K830876](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K830876.md) | PREP-CHECK | General Devices | May 18, 1983 | SESE |
| [K830823](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K830823.md) | Z VIEW METER MODEL 300 | Lintronics Industries, Inc. | May 18, 1983 | SESE |
| [K813358](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K813358.md) | GERARD MEDICAL ELECTRODE TESTER | Gerard Medical Enterprises, Inc. | Dec 29, 1981 | SESE |
| [K780501](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K780501.md) | ELECTRODE TESTER | Mg Medical Electronics | May 19, 1978 | SESE |
| [K771014](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/KRC/K771014.md) | TS-100 TEST SYSTEM | Delta Medical Industries | Jun 14, 1977 | SESE |

## Top Applicants

- Circadian, Inc. — 2 clearances
- Aequitron Medical, Inc. — 1 clearance
- Delta Medical Industries — 1 clearance
- E.B.S., Inc. — 1 clearance
- General Devices — 1 clearance

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

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