The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Electrotherm Models Tc-100 & M-99.
| Device ID | K771995 |
| 510k Number | K771995 |
| Device Name: | ELECTROTHERM MODELS TC-100 & M-99 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-21 |
| Decision Date | 1977-11-22 |