510(k) K953054

AM 260 OHM by Electone, Inc. — Product Code ESD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 15, 1995
Date Received: June 30, 1995
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 Electone, Inc.

K973266 — Z DEQ-II (September 23, 1997)
K961084 — AM 400 (April 18, 1996)
K955702 — SONATA U-01 (February 22, 1996)
K953050 — Z33 (August 22, 1995)
K953047 — Z20 (August 22, 1995)
K953053 — AM 260 PP (August 15, 1995)
K953049 — Z24 (August 15, 1995)
K953048 — Z22 (August 15, 1995)
K953052 — AM 260 K-AMP (August 15, 1995)
K953051 — Z35 (August 15, 1995)

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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)