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510(k) K974287

FM RECEIVER - AUDITORY TRAINER by Phonic Ear, Inc. — Product Code EPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1998
Date Received
November 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Group And Auditory Trainer
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type

Other clearances by Phonic Ear, Inc.

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  • K950730 — GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (June 30, 1995)
  • K940313 — PHONIC EAR (March 22, 1994)
  • K923234 — PE 400IR, PE 400T, PE 400E (September 29, 1992)
  • K922720 — GROUP AUDITORY TRAINING SYSTEM (August 24, 1992)
  • K912356 — GROUP AUDITORY TRAINER,FM RECEIVER (August 15, 1991)
  • K893431 — AUDITORY TRAINER PE150R FM RECEIVER (August 21, 1989)
  • K882409 — PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER (July 5, 1988)
  • K881099 — PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER (June 7, 1988)

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  • K974658 — INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIV (February 25, 1998)
  • K970665 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K970687 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K960567 — HF MEGA EAR (October 16, 1996)
  • K950730 — GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (June 30, 1995)
  • K941768 — PHONAK MICROVOX RESONAL FM SYSTEM (June 24, 1994)
  • K940313 — PHONIC EAR (March 22, 1994)
  • K923234 — PE 400IR, PE 400T, PE 400E (September 29, 1992)