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510(k) K974257

RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) by Resound Corp. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1997
Date Received
November 13, 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.

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  • K960052 — RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (March 12, 1996)
  • K960229 — RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM (March 7, 1996)

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