The following data is part of a premarket notification filed by Share Int'l with the FDA for Share Int'l Tdm.
| Device ID | K832067 |
| 510k Number | K832067 |
| Device Name: | SHARE INT'L TDM |
| Classification | Device, Skin Potential Measurement |
| Applicant | SHARE INT'L 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 | 1983-06-27 |
| Decision Date | 1983-10-27 |