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510(k) K950350

THEMALATOR. MODELS T-4-S, T-8-S, ETC. by Whitehall/Div Columbus Mckennon Corp. — Product Code IRQ

K950350 is an FDA 510(k) premarket notification submitted by Whitehall/Div Columbus Mckennon Corp. for the device "THEMALATOR. MODELS T-4-S, T-8-S, ETC.". The FDA issued a decision of Substantially Equivalent on March 24, 1995. The device falls under product code IRQ (Unit, Heating, Powered), a Class I device regulated under 21 CFR 890.5950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
January 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Heating, Powered
Device Class
Class I
Regulation Number
890.5950
Review Panel
PM
Submission Type

Other clearances for product code IRQ

  • K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (September 14, 2005)
  • K924023 — FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (April 14, 1993)
  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K861340 — R1750 AND R1424 POWERED HEATING UNITS (May 2, 1986)
  • K832177 — PULSAIR MODEL SP-1 (December 9, 1983)
  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)

FDA data resources