FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Diagnostic electromyography, nerve conduction velocity measurement, evoked response electrical stimulator, evoked response photic stimulator, and evoked response auditory stimulator.

Device Description

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AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "TOENNIES NEUROSCREEN SYSTEM." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance, specific study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies.

Therefore, I cannot provide the requested table and study details based on the input text. The letter is a regulatory approval document, not a scientific study report.

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K Number

K960078

Device Name

ASTHMA MONITOR

Manufacturer

ERICH JAEGER, INC.

Date Cleared

1996-09-20

(259 days)

Product Code