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510(k) K830418

TACTAID by Audiological Engineering Corp. — Product Code LRA

K830418 is an FDA 510(k) premarket notification submitted by Audiological Engineering Corp. for the device "TACTAID". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1983
Date Received
February 8, 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)
  • K831501 — TACTIL EAR (August 26, 1983)
  • K813057 — VIBRO-COM COMMUNICATOR #8827 (December 2, 1981)

FDA data resources