The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Mon-a-therm Subcutaneous Temp. Sensor.
| Device ID | K853392 |
| 510k Number | K853392 |
| Device Name: | MON-A-THERM SUBCUTANEOUS TEMP. SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MON-A-THERM, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Contact | Sheryl A Marcouille |
| Correspondent | Sheryl A Marcouille MON-A-THERM, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-13 |
| Decision Date | 1985-11-22 |