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510(k) K950730

GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) by Phonic Ear, Inc. — Product Code EPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1995
Date Received
February 16, 1995
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.

  • K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (December 23, 2004)
  • K974658 — INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIV (February 25, 1998)
  • K974287 — FM RECEIVER - AUDITORY TRAINER (February 10, 1998)
  • 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)
  • K974287 — FM RECEIVER - AUDITORY TRAINER (February 10, 1998)
  • K970687 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K970665 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K960567 — HF MEGA EAR (October 16, 1996)
  • 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)