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510(k) K050524

EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 by Marda Medical, Inc. — Product Code IRQ

K050524 is an FDA 510(k) premarket notification submitted by Marda Medical, Inc. for the device "EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000". The FDA issued a decision of Substantially Equivalent on September 14, 2005. 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
September 14, 2005
Date Received
March 2, 2005
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

  • K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC. (March 24, 1995)
  • 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