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510(k) K944078

PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT by Argosy Electronics — Product Code ESD

K944078 is an FDA 510(k) premarket notification submitted by Argosy Electronics for the device "PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT". The FDA issued a decision of Substantially Equivalent on October 21, 1994. The device falls under product code ESD (Hearing Aid, Air-Conduction, Prescription), a Class I device regulated under 21 CFR 874.3300. Argosy Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 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

  • K974242 — ARGOSY PROGRAMMABLE ONQUE (January 20, 1998)
  • 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)
  • K952452 — OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL (July 6, 1995)
  • K952450 — WIDE DYNAMIC RANGE COMPRESSION 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)
  • K952455 — IMPROVED MANHATTAN II (June 21, 1995)
  • K952454 — EXPANDER WITH ACTIVE TONE CONTROL (June 21, 1995)

Other clearances for product code ESD

  • K232999 — Lyric4 Hearing Aid (April 11, 2024)
  • 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)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)

FDA data resources