Phoenix System Seven Audiometer

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

Full name

Phoenix System Seven.

510(k) Number

K862592 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K850108 Active Cleared 11 Apr 1985

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• What is the Phoenix System Seven used for?

  The Phoenix System Seven is an audiometer designed to evaluate hearing thresholds across different frequencies. It uses calibrated pure-tone signals and speech stimuli to assess auditory function, helping clinicians diagnose and differentiate between conductive, sensorineural, or mixed hearing loss. This information supports treatment planning for patients with hearing impairments in audiology and ENT settings.

• Is the Phoenix System Seven reusable or single-use?

  The Phoenix System Seven is supplied as a reusable medical instrument. It is intended for repeated use in clinical environments like audiology clinics and ENT departments, following standard maintenance and calibration protocols for audiometric equipment.

• Does the Phoenix System Seven require special storage or handling?

  The Phoenix System Seven does not have specific sterility or single-use requirements. However, since it is a reusable device, it must be maintained and calibrated according to standard audiometric equipment protocols to ensure accurate and reliable performance. Proper storage should follow manufacturer guidelines to protect the device from environmental factors.

• What regulatory approval does the Phoenix System Seven hold?

  The Phoenix System Seven holds an FDA 510(k) clearance (K862592) for substantial equivalence, classifying it as a Class II device under FDA regulations (874.1050). This clearance confirms that the device meets FDA standards for safety and effectiveness as a diagnostic audiometer.

• Can the Phoenix System Seven be used in MRI environments?

  No special MRI safety considerations are noted for the Phoenix System Seven. However, it is designed for standard clinical settings, and users should ensure compliance with facility-specific MRI safety protocols if the device is used in proximity to MRI equipment.