← Product Code [GYB](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB) · K803151

# ECG & ULTRASOUND GELS, CREAMS & LOTION (K803151)

_Abco Dealers, Inc. · GYB · Dec 30, 1980 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB/K803151

## Device Facts

- **Applicant:** Abco Dealers, Inc.
- **Product Code:** [GYB](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB.md)
- **Decision Date:** Dec 30, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1275
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB/K803151](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYB/K803151)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
