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510(k) K970519

UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) by Unitron Industries, Inc. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1997
Date Received
February 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Air-Conduction, Prescription
Device Class
Class I
Regulation Number
874.3300
Review Panel
EN
Submission Type

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

Other clearances by Unitron Industries, Inc.

  • K974340 — UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE (December 12, 1997)
  • K974339 — UNITRON MODEL SOUND F/XD PROGRAMMABLE (December 12, 1997)
  • K974338 — UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) (December 12, 1997)
  • K970692 — UNITRON MODEL SOUND F/X CIC (May 8, 1997)
  • K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (November 27, 1996)
  • K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (November 27, 1996)
  • K964503 — UNITRON MODEL SOUND F/X +4 (November 27, 1996)
  • K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (November 27, 1996)
  • K964502 — UNITRON MODEL SOUND F/XP +4 (November 27, 1996)
  • K964504 — UNITRON MODEL ICON AOHPL +4 (November 27, 1996)

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  • K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (April 24, 2001)
  • K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (March 12, 1999)
  • K974751 — TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (March 6, 1998)
  • K974242 — ARGOSY PROGRAMMABLE ONQUE (January 20, 1998)
  • K973880 — SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (January 12, 1998)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)