Madsen Igo-HAT1500 Hearing Aid Dispenser System

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K884371 ↗

FDA Product Code

ETW

FDA applicant

Madsen Electronics (Canada) , Ltd.

Device Class

Class II

Regulation

21 CFR Part 874.3310

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• UP800 a Universal Printer

  Class II

  FDA 510(k) K845050 Active Cleared 29 May 1985

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  Class II

  FDA 510(k) K931325 Active Cleared 18 Feb 1994

• Digital Screening Audiometer DSA6214

  Class II

  FDA 510(k) K854534 Active Cleared 13 Feb 1986

• Mta 86

  Not classified

  FDA 510(k) K844592 Active Cleared 22 May 1985

• Hearing Aid Test System Model Hat 1000

  Class II

  FDA 510(k) K870229 Active Cleared 13 Mar 1987

• Plotter Model (MP100)

  Not classified

  FDA 510(k) K861905 Active Cleared 26 Nov 1986

See all devices from Madsen Electronics (Canada), Ltd. →