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510(k) K812701

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

K812701 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "ORTHO-THERM INFRARED SENSOR". The FDA issued a decision of Substantially Equivalent on October 13, 1981. The device falls under product code IYM (System, Telethermographic, Infrared), a Class III device regulated under 21 CFR 884.2980. Orthion Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Orthion Corp.

  • K832546 — MARK V HIGH VOLTAGE GALVANIC STIMULATORR (October 14, 1983)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (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)
  • K823151 — OB TRIPP TRANSPORT CHAIR (November 5, 1982)
  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (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)

FDA data resources