The following data is part of a premarket notification filed by Orthion Corp. with the FDA for Ortho-therm Infrared Sensor.
| Device ID | K812701 |
| 510k Number | K812701 |
| Device Name: | ORTHO-THERM INFRARED SENSOR |
| Classification | System, Telethermographic, Infrared |
| Applicant | ORTHION CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYM |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-23 |
| Decision Date | 1981-10-13 |