Home / 510(k) Clearances / K943035

510(k) K943035

P.A.T. SYSTEM by Mathews Assoc., Inc. — Product Code ILQ

K943035 is an FDA 510(k) premarket notification submitted by Mathews Assoc., Inc. for the device "P.A.T. SYSTEM". The FDA issued a decision of Substantially Equivalent on October 4, 1994. 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
October 4, 1994
Date Received
June 27, 1994
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

  • K162817 — Noddle(TM) (January 18, 2017)
  • 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)
  • K924013 — MACAW (March 4, 1993)
  • K924030 — SCRIBE (March 4, 1993)

FDA data resources