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510(k) K800491

GRAPHIC STRESS TELETHERMOMETRY by Gst Laboratories of Ca, Inc. — Product Code IYM

K800491 is an FDA 510(k) premarket notification submitted by Gst Laboratories of Ca, Inc. for the device "GRAPHIC STRESS TELETHERMOMETRY". The FDA issued a decision of SESP on March 4, 1980. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980. Gst Laboratories of Ca, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESP ()
Decision Date
March 4, 1980
Date Received
March 4, 1980
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 by Gst Laboratories of Ca, Inc.

  • K842878 — GST SYSTEM THERMOGRAPHIC APPLICATION (March 22, 1985)

Other clearances for product code IYM

  • K863736 — FMS MODEL 110 (December 29, 1986)
  • K852950 — VISITHERM (February 7, 1986)
  • K823041 — JEOL MODEL #JTG-500M (November 24, 1982)
  • K812799 — DCATS (October 20, 1981)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)
  • K801553 — THERMOCOMP (October 31, 1980)
  • K760999 — THERMOGRAPH, MEDICAL (November 19, 1976)

FDA data resources