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510(k) K862162

PHONIC EAR, MODEL PE 1800 by Phonic Ear, Inc. — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1986
Date Received
June 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

Other clearances by Phonic Ear, Inc.

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  • 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)

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