Dcats
FDA 510(k) K812799 · Dorex, Inc.
510(k) numberK812799
Submission
- Device name
- Dcats
- Applicant
- Dorex, Inc.
Mchenry, IL, US - Received
- October 6, 1981
- Decision date
- October 20, 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 |
| 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 |
More from Honeywell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023434 | Dorex Spectrum 9000MB Thermography SystemLHQ · Special | 11/14/2002SE |
Questions and answers
When was Dcats cleared by the FDA?
Dcats (K812799) received a 510(k) decision of Substantially Equivalent on October 20, 1981, 14 days after the submission was received.
What is the product code of K812799?
The FDA product code is IYM – System, Telethermographic, Infrared, a Class III (high risk) device regulated under 21 CFR 884.2980.