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510(k) K812701

ORTHO-THERM INFRARED SENSOR by Orthion Corp. — Product Code IYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1981
Date Received
September 23, 1981
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

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  • K823151 — OB TRIPP TRANSPORT CHAIR (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (November 5, 1982)
  • K823149 — OB TILT TABLE (November 5, 1982)
  • K823152 — OB HELP ARM (November 5, 1982)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)

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)
  • K801553 — THERMOCOMP (October 31, 1980)
  • K800491 — GRAPHIC STRESS TELETHERMOMETRY (March 4, 1980)
  • K760999 — THERMOGRAPH, MEDICAL (November 19, 1976)