510(k) K944077

PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM by Argosy Electronics — Product Code ESD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 12, 1994
Date Received: August 22, 1994
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 Argosy Electronics

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K971699 — ARGOSY DYNAMEQ (July 3, 1997)
K961729 — ARGOSY PROGRAMMABLE (May 29, 1996)
K954038 — K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUME (September 18, 1995)
K952450 — WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL (July 6, 1995)
K952452 — OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL (July 6, 1995)
K952451 — CLASS D LINEAR WITH ACTIVE TONE CONTROL (July 6, 1995)
K952453 — INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROL (June 21, 1995)
K952454 — EXPANDER WITH ACTIVE TONE CONTROL (June 21, 1995)
K952455 — IMPROVED MANHATTAN II (June 21, 1995)

Other clearances for product code ESD

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K130790 — LYRIC2 (June 27, 2013)
K081136 — LYRIC HEARING AID (May 8, 2008)
K021867 — INSOUND XT SERIES HEARING AID (November 19, 2002)
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)