The following data is part of a premarket notification filed by Flir Medical Systems with the FDA for Fms Model 110.
| Device ID | K863736 |
| 510k Number | K863736 |
| Device Name: | FMS MODEL 110 |
| Classification | System, Telethermographic, Infrared |
| Applicant | FLIR MEDICAL SYSTEMS 16505 S.W. 72ND AVE. Portland, OR 97224 |
| Contact | Clark W Wingert |
| Correspondent | Clark W Wingert FLIR MEDICAL SYSTEMS 16505 S.W. 72ND AVE. Portland, OR 97224 |
| Product Code | IYM |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-12-29 |