Ortho-Therm Infrared Sensor
FDA 510(k) K812701 · Orthion Corp.
510(k) numberK812701
Submission
- Device name
- Ortho-Therm Infrared Sensor
- Applicant
- Orthion Corp.
Mchenry, IL, US - Received
- September 23, 1981
- Decision date
- October 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IYM – System, Telethermographic, Infrared
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 884.2980
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code IYM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K863736 | FMS Model 110IYM · Traditional | Flir Medical Systems | 12/29/1986SN |
| K852950 | VisithermIYM · Traditional | C.D. Regelin & Associates, Inc. | 02/07/1986SE |
| K823041 | Jeol Model #JTG-500MIYM · Traditional | Jeol | 11/24/1982SE |
| K812799 | DcatsIYM · Traditional | Dorex, Inc. | 10/20/1981SE |
| K801553 | ThermocompIYM · Traditional | Hospital Financial Corp. | 10/31/1980SE |
| K800491 | Graphic Stress TelethermometryIYM · Traditional | Gst Laboratories of Ca, Inc. | 03/04/1980SESP |
| K760999 | Thermograph, MedicalIYM · Traditional | Honeywell, Inc. | 11/19/1976SE |
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Questions and answers
When was Ortho-Therm Infrared Sensor cleared by the FDA?
Ortho-Therm Infrared Sensor (K812701) received a 510(k) decision of Substantially Equivalent on October 13, 1981, 20 days after the submission was received.
What is the product code of K812701?
The FDA product code is IYM – System, Telethermographic, Infrared, a Class III (high risk) device regulated under 21 CFR 884.2980.