The following data is part of a premarket notification filed by Spelson Research Laboratories, Inc. with the FDA for Skin Galvanometer.
| Device ID | K823194 |
| 510k Number | K823194 |
| Device Name: | SKIN GALVANOMETER |
| Classification | Device, Skin Potential Measurement |
| Applicant | SPELSON RESEARCH LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HCJ |
| CFR Regulation Number | 882.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-26 |
| Decision Date | 1983-01-21 |