The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Airway Temperature Sensor.
| Device ID | K821505 |
| 510k Number | K821505 |
| Device Name: | AIRWAY TEMPERATURE SENSOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MON-A-THERM, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-20 |
| Decision Date | 1982-12-09 |