SHARE INT'L TDM
Device Facts
| Record ID | K832067 |
|---|---|
| Device Name | SHARE INT'L TDM |
| Applicant | Share Int'L |
| Product Code | HCJ · Neurology |
| Decision Date | Oct 27, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1560 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.
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.
