← Product Code [GZO](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO) · K001347

# MERIDIAN-II AND MERDIAN-PLUS (K001347)

_Meridian Co., Ltd. · GZO · Nov 3, 2000 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K001347

## Device Facts

- **Applicant:** Meridian Co., Ltd.
- **Product Code:** [GZO](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO.md)
- **Decision Date:** Nov 3, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1540
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

## 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 § 882.9.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K001347](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZO/K001347)

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