The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Thermal Well Temperature Sensor.
| Device ID | K821504 |
| 510k Number | K821504 |
| Device Name: | THERMAL WELL TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MON-A-THERM, 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 | 1982-05-20 |
| Decision Date | 1982-06-23 |