← Product Code [DRX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX) · K831977

# C TEC SERIES 9000 E.C.G. ELECTRODE (K831977)

_Speywood Medical, Ltd. · DRX · Sep 9, 1983 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K831977

## Device Facts

- **Applicant:** Speywood Medical, Ltd.
- **Product Code:** [DRX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX.md)
- **Decision Date:** Sep 9, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2360
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K831977](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K831977)

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