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510(k) K831501

TACTIL EAR by Ear Three Systems — Product Code LRA

K831501 is an FDA 510(k) premarket notification submitted by Ear Three Systems for the device "TACTIL EAR". The FDA issued a decision of Substantially Equivalent on August 26, 1983. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
May 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Tactile
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances for product code LRA

  • K883853 — ETA (November 17, 1988)
  • K862471 — WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER (September 12, 1986)
  • K851441 — TACTICON 1600 (June 27, 1985)
  • K851655 — TEACHER TM (June 20, 1985)
  • K843433 — KANIEVSKI SENSORY AID OR DEVICE (November 14, 1984)
  • K830418 — TACTAID (March 10, 1983)
  • K813057 — VIBRO-COM COMMUNICATOR #8827 (December 2, 1981)

FDA data resources