Dahlberg Model GF Microprocessor Audiometer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K854835 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Dahlbert Model De Behing-the-Ear Hearing Aid

  Class I

  FDA 510(k) K851868 Active Cleared 1 Jul 1985

• Dahlberg Model Ef Behind-the-Ear Hearing Aid

  Class I

  FDA 510(k) K860671 Active Cleared 3 Apr 1986

• Model Uc in-the-Canal Hearing Aid

  Class I

  FDA 510(k) K862103 Active Cleared 23 Jun 1986

• Dahlberg Model Ee Behind-the-Ear Hearing Aid

  Class I

  FDA 510(k) K862099 Active Cleared 23 Jun 1986

• Dahlberg Model Dd Behing-the-Ear Hearing Aid

  Class I

  FDA 510(k) K851867 Active Cleared 5 Jul 1985

• Model Da Behind-the-Ear Hearing Aid

  Class I

  FDA 510(k) K851810 Active Cleared 5 Jul 1985

See all devices from Miracle-Ear/Dahlberg, Inc. →

• What clinical applications does the Dahlberg Model GF Microprocessor Audiometer support in audiology practice?

  The Dahlberg Model GF Microprocessor Audiometer is specifically designed for measuring hearing acuity and assessing auditory function. It supports pure-tone and speech audiometry testing, which are essential for evaluating hearing loss and determining auditory thresholds across different frequencies. This makes it ideal for diagnosing and monitoring conditions in audiology clinics, otolaryngology offices, and hearing healthcare facilities.

• Is the Dahlberg Model GF Microprocessor Audiometer intended for single-use or reusable in clinical settings?

  The device is supplied as a reusable medical instrument, meaning it is not intended for single-use. Proper calibration and maintenance protocols, as outlined by the manufacturer, are required to ensure accurate and reliable performance over repeated use in clinical environments.

• What regulatory pathway was followed for the FDA clearance of this audiometer?

  The Dahlberg Model GF Microprocessor Audiometer received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent under 21 CFR 874.1050. The device was reviewed by the Ear, Nose, and Throat (ENT) Advisory Committee and holds the clearance number K854835, confirming its compliance with regulatory standards for Class II medical devices.

• Does this audiometer come with any specific sterility or MRI safety information?

  The provided data does not include any details regarding sterility or MRI safety for the Dahlberg Model GF Microprocessor Audiometer. Users should refer to the manufacturer’s guidelines for proper handling, cleaning, and environmental considerations, particularly if used in proximity to MRI equipment.