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510(k) K905474

THE EYEGAZE SYSTEM by Lc Technologies, Inc. — Product Code ILQ

K905474 is an FDA 510(k) premarket notification submitted by Lc Technologies, Inc. for the device "THE EYEGAZE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 28, 1991. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1991
Date Received
December 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type

Other clearances for product code ILQ

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  • K943035 — P.A.T. SYSTEM (October 4, 1994)
  • K930044 — COMFORT KEYBOARD SYSTEM (July 14, 1994)
  • K931855 — LIGHTWRITER (May 10, 1994)
  • K935244 — R & D BATTERIES, INC. PART NUMBER 5113 (April 19, 1994)
  • K935981 — MLT-2 (February 17, 1994)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K924014 — SECRETARY (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)

FDA data resources