The following data is part of a premarket notification filed by T. G. & E. Medical with the FDA for Skin Temperature Sensing Vinyl Strip.
| Device ID | K813199 |
| 510k Number | K813199 |
| Device Name: | SKIN TEMPERATURE SENSING VINYL STRIP |
| Classification | Strip, Temperature, Forehead, Liquid Crystal |
| Applicant | T. G. & E. MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPD |
| CFR Regulation Number | 880.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-13 |
| Decision Date | 1982-03-05 |