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510(k) K043090

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS by Phonic Ear, Inc. — Product Code LZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2004
Date Received
November 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Assistive Listening
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)

Other clearances for product code LZI

  • K970974 — WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (May 2, 1997)
  • K970340 — AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER (March 26, 1997)
  • K954748 — POCKETALKER PRO (November 22, 1995)
  • K952057 — LISTENAIDER II (June 21, 1995)
  • K934805 — HEARIT (February 7, 1994)
  • K904755 — ACOUSTIQ LISTENING DEVICE (January 29, 1991)