K863736 is an FDA 510(k) clearance for the FMS MODEL 110. This device is classified as a System, Telethermographic, Infrared (Class III - Premarket Approval, product code IYM).
Submitted by Flir Medical Systems (Portland, US). The FDA issued a Cleared decision on December 29, 1986, 97 days after receiving the submission on September 23, 1986.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2980.
| 510(k) Number | K863736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | September 23, 1986 |
| Decision Date | December 29, 1986 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IYM — System, Telethermographic, Infrared |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 884.2980 |