The following data is part of a premarket notification filed by Gics Pharmaceuticals with the FDA for Tms 1000 Temp. Monitor & Probes.
| Device ID | K800849 |
| 510k Number | K800849 |
| Device Name: | TMS 1000 TEMP. MONITOR & PROBES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | GICS PHARMACEUTICALS 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 | 1980-04-15 |
| Decision Date | 1980-05-08 |