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510(k) K964504

UNITRON MODEL ICON AOHPL +4 by Unitron Industries, Inc. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1996
Date Received
November 8, 1996
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.

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  • K974339 — UNITRON MODEL SOUND F/XD PROGRAMMABLE (December 12, 1997)
  • K974340 — UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE (December 12, 1997)
  • K970692 — UNITRON MODEL SOUND F/X CIC (May 8, 1997)
  • K970519 — UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) (April 24, 1997)
  • K964510 — UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (November 27, 1996)
  • K964508 — UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (November 27, 1996)
  • K964511 — UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (November 27, 1996)
  • K964503 — UNITRON MODEL SOUND F/X +4 (November 27, 1996)
  • K964502 — UNITRON MODEL SOUND F/XP +4 (November 27, 1996)

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