MERIDIAN-II AND MERDIAN-PLUS
Device Facts
| Record ID | K001347 |
|---|---|
| Device Name | MERIDIAN-II AND MERDIAN-PLUS |
| Applicant | Meridian Co., Ltd. |
| Product Code | GZO · Neurology |
| Decision Date | Nov 3, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1540 |
| Device Class | Class 2 |
Regulatory Classification
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.
