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510(k) K992553

IQ CHAMBERS by Dormer Laboratories, Inc. — Product Code KXF

K992553 is an FDA 510(k) premarket notification submitted by Dormer Laboratories, Inc. for the device "IQ CHAMBERS". The FDA issued a decision of Substantially Equivalent on April 12, 2000. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2000
Date Received
July 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

Other clearances for product code KXF

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K103409 — ALLERGEAZE R CLEAR (March 15, 2011)
  • K063160 — ALLERGEAZE PATCH TEST CHAMBERS (December 22, 2006)
  • K013820 — FINN CHAMBER (R) (January 30, 2002)
  • K870762 — EAR APPLICATOR, CATALOG NO. 2229 (March 6, 1987)
  • K843720 — COTTON TIPPED APPLICATORS, SINGLE (October 4, 1984)
  • K820962 — COTTON SWABS (April 20, 1982)
  • K813506 — FARRORS TMJ CASSETTE HOLDER (January 29, 1982)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)
  • K802580 — SUBCLAVIAN CATHETER INSERTION TRAY (November 12, 1980)

FDA data resources