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K Number
K961638
Device Name
MEDILOG MPA-S
Manufacturer
OXFORD INSTRUMENTS MEDICAL SYSTEMS
Date Cleared
1997-01-17

(263 days)

Product Code
OLV
Regulation Number
882.1400
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Recording of a physiological signals (single channel of EEG, and or recording of ECG signals at 64 Hz) that are required to aid in the diagnoses of sleep related disorders.

Device Description

Medilog MPA-S Recorder

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "Medilog MPA-S Recorder." This document primarily addresses regulatory approval and does not contain information about acceptance criteria, study methodologies, or performance data for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).