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510(k) K823041

JEOL MODEL #JTG-500M by Jeol — Product Code IYM

K823041 is an FDA 510(k) premarket notification submitted by Jeol for the device "JEOL MODEL #JTG-500M". The FDA issued a decision of Substantially Equivalent on November 24, 1982. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1982
Date Received
October 14, 1982
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

Other clearances for product code IYM

  • K863736 — FMS MODEL 110 (December 29, 1986)
  • K852950 — VISITHERM (February 7, 1986)
  • K812799 — DCATS (October 20, 1981)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)
  • K801553 — THERMOCOMP (October 31, 1980)
  • K800491 — GRAPHIC STRESS TELETHERMOMETRY (March 4, 1980)
  • K760999 — THERMOGRAPH, MEDICAL (November 19, 1976)

FDA data resources