21 CFR 882.1560 — Device, Skin Potential Measurement
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1560
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HCJ | Device, Skin Potential Measurement | 2 | 2 |
Special Controls
HCJ — Device, Skin Potential Measurement
*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.
eCFR
