Jeol Model #JTG-500M
FDA 510(k) K823041 · Jeol
510(k) numberK823041
Submission
- Device name
- Jeol Model #JTG-500M
- Applicant
- Jeol
Mchenry, IL, US - Received
- October 14, 1982
- Decision date
- November 24, 1982
- 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 |
| K812799 | DcatsIYM · Traditional | Dorex, Inc. | 10/20/1981SE |
| K812701 | Ortho-Therm Infrared SensorIYM · Traditional | Orthion Corp. | 10/13/1981SE |
| 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 |
Questions and answers
When was Jeol Model #JTG-500M cleared by the FDA?
Jeol Model #JTG-500M (K823041) received a 510(k) decision of Substantially Equivalent on November 24, 1982, 41 days after the submission was received.
What is the product code of K823041?
The FDA product code is IYM – System, Telethermographic, Infrared, a Class III (high risk) device regulated under 21 CFR 884.2980.