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510(k) K914259

TOUCH TALKER by Prentke Romich Co. — Product Code ILQ

K914259 is an FDA 510(k) premarket notification submitted by Prentke Romich Co. for the device "TOUCH TALKER". The FDA issued a decision of Substantially Equivalent on February 27, 1992. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Prentke Romich Co. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1992
Date Received
September 23, 1991
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 by Prentke Romich Co.

  • K961306 — DELTATALKER WITH INFRARED (June 27, 1996)
  • K944585 — SCANNING DIRECTOR (February 21, 1995)
  • K933207 — WALKERTALKER (March 28, 1994)
  • K935317 — ALPHA TALKER (March 28, 1994)
  • K925387 — LIBERATOR (March 29, 1993)
  • K925527 — LIGHT TALKER (March 22, 1993)
  • K902664 — HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 (July 25, 1990)
  • K902206 — CONTROL 1 ENVIRONMENTAL CONTROL (May 29, 1990)

Other clearances for product code ILQ

  • K162817 — Noddle(TM) (January 18, 2017)
  • 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