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510(k) K924023

FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 by Ferno — Product Code IRQ

K924023 is an FDA 510(k) premarket notification submitted by Ferno for the device "FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917". The FDA issued a decision of Substantially Equivalent on April 14, 1993. The device falls under product code IRQ (Unit, Heating, Powered), a Class I device regulated under 21 CFR 890.5950. Ferno has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1993
Date Received
August 11, 1992
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 by Ferno

  • K932260 — FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE (September 9, 1993)
  • K931346 — FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT (August 25, 1993)
  • K924669 — FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W (April 29, 1993)
  • K914125 — FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 (October 25, 1991)

Other clearances for product code IRQ

  • K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (September 14, 2005)
  • K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC. (March 24, 1995)
  • 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