Home / 510(k) Clearances / K852950

510(k) K852950

VISITHERM by C.D. Regelin & Associates, Inc. — Product Code IYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1986
Date Received
July 11, 1985
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)
  • 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)
  • K800491 — GRAPHIC STRESS TELETHERMOMETRY (March 4, 1980)
  • K760999 — THERMOGRAPH, MEDICAL (November 19, 1976)