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510(k) K851655

TEACHER TM by Monargue Intl. — Product Code LRA

K851655 is an FDA 510(k) premarket notification submitted by Monargue Intl. for the device "TEACHER TM". The FDA issued a decision of Substantially Equivalent on June 20, 1985. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1985
Date Received
April 22, 1985
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)
  • K843433 — KANIEVSKI SENSORY AID OR DEVICE (November 14, 1984)
  • K831501 — TACTIL EAR (August 26, 1983)
  • K830418 — TACTAID (March 10, 1983)
  • K813057 — VIBRO-COM COMMUNICATOR #8827 (December 2, 1981)

FDA data resources