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510(k) K974658

INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT by Phonic Ear, Inc. — Product Code EPF

K974658 is an FDA 510(k) premarket notification submitted by Phonic Ear, Inc. for the device "INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT". The FDA issued a decision of Substantially Equivalent on February 25, 1998. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Phonic Ear, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1998
Date Received
December 15, 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.

  • K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (December 23, 2004)
  • K974287 — FM RECEIVER - AUDITORY TRAINER (February 10, 1998)
  • 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)

Other clearances for product code EPF

  • K133352 — HYPERSOUND AUDIO SYSTEM (HSS) (February 12, 2014)
  • K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (October 6, 1998)
  • K974287 — FM RECEIVER - AUDITORY TRAINER (February 10, 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)

FDA data resources