510(k) K863736
K863736 is an FDA 510(k) premarket notification submitted by Flir Medical Systems for the device "FMS MODEL 110". The FDA issued a decision of SN on December 29, 1986. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980.
Clearance Details
- Decision
- SN ()
- Decision Date
- December 29, 1986
- Date Received
- September 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic, Infrared
- Device Class
- Class III
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type