510(k) K823041
- Device
- JEOL MODEL #JTG-500M
- Applicant
- JEOL
- 510(k) number
- K823041
- Product code
- IYM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-24
- Date received
- 1982-10-14
- Regulation
- 884.2980
- Classification name
- System, Telethermographic, Infrared
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863736 | FMS MODEL 110 | Flir Medical Systems | 1986-12-29 |
| K852950 | VISITHERM | C.D. Regelin & Associates, Inc. | 1986-02-07 |
| K812799 | DCATS | Dorex, Inc. | 1981-10-20 |
| K812701 | ORTHO-THERM INFRARED SENSOR | Orthion Corp. | 1981-10-13 |
| K801553 | THERMOCOMP | Hospital Financial Corp. | 1980-10-31 |
| K800491 | GRAPHIC STRESS TELETHERMOMETRY | Gst Laboratories of Ca, Inc. | 1980-03-04 |
| K760999 | THERMOGRAPH, MEDICAL | Honeywell, Inc. | 1976-11-19 |
Legacy Summary#
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FDA Review#
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