(79 days)
The Otodynamics ILO288 ECHOPORTplus OAE System is designed to perform an auditory screening function by objectively testing for normal function of the cochlea. The system is designed to operate standalone, or optionally interface to an IBM compatible PC, using the parallel port.
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This document is a 510(k) clearance letter from the FDA for the ILO288 ECHOPORTplus OAE System. It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific information laid out in your numbered points, as that data is not present in the provided text.
§ 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.