(79 days)
The Maico MB 11 is intended to generate evoked auditory brainstem response (ABR) - based measurements for both child and newborn hearing screening.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Maico MB 11" or "MB 11". This document primarily focuses on the regulatory approval process and includes the device’s indications for use. It does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document is a regulatory approval, not a scientific study report.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).