(244 days)
Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers. Clarujust™ is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
Clarujust™ is an automated testing software accessory for ANSI S3.6 speech audiometers.
I am sorry, but the provided text from the FDA 510(k) letter for the Audigence Clarujust™ does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets those criteria. The letter is a notification of substantial equivalence for marketing the device and details regulatory requirements, but it does not include performance data or study specifics.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.