HCJ · Device, Skin Potential Measurement
Neurology · 21 CFR 882.1560 · Class 2
Overview
| Product Code | HCJ |
|---|---|
| Device Name | Device, Skin Potential Measurement |
| Regulation | 21 CFR 882.1560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832067 | SHARE INT'L TDM | Share Int'L | Oct 27, 1983 | SESE |
| K823194 | SKIN GALVANOMETER | Spelson Research Laboratories, Inc. | Jan 21, 1983 | SESE |
Top Applicants
- Share Int'L — 1 clearance
- Spelson Research Laboratories, Inc. — 1 clearance
