510(k) K863736
- Device
- FMS MODEL 110
- Applicant
- FLIR MEDICAL SYSTEMS
- 510(k) number
- K863736
- Product code
- IYM
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1986-12-29
- Date received
- 1986-09-23
- 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#
- Contact
- CLARK W WINGERT
- Address
- 16505 SW 72nd Ave. Portland OR US 97224 97224
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IYM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852950 | VISITHERM | C.D. Regelin & Associates, Inc. | 1986-02-07 |
| K823041 | JEOL MODEL #JTG-500M | Jeol | 1982-11-24 |
| 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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