Thermocomp
FDA 510(k) K801553 · Hospital Financial Corp.
510(k) numberK801553
Submission
- Device name
- Thermocomp
- Applicant
- Hospital Financial Corp.
Mchenry, IL, US - Received
- July 8, 1980
- Decision date
- October 31, 1980
- 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 |
| K812701 | Ortho-Therm Infrared SensorIYM · Traditional | Orthion Corp. | 10/13/1981SE |
| K800491 | Graphic Stress TelethermometryIYM · Traditional | Gst Laboratories of Ca, Inc. | 03/04/1980SESP |
| K760999 | Thermograph, MedicalIYM · Traditional | Honeywell, Inc. | 11/19/1976SE |
Questions and answers
When was Thermocomp cleared by the FDA?
Thermocomp (K801553) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 115 days after the submission was received.
What is the product code of K801553?
The FDA product code is IYM – System, Telethermographic, Infrared, a Class III (high risk) device regulated under 21 CFR 884.2980.