The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Sc-it Impedance Tester.
| Device ID | K820040 |
| 510k Number | K820040 |
| Device Name: | SC-IT IMPEDANCE TESTER |
| Classification | Tester, Electrode/lead, Electroencephalograph |
| Applicant | CADWELL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYA |
| CFR Regulation Number | 882.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-07 |
| Decision Date | 1982-01-28 |