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Digitrace Home Monit Comp/Elb Eeg Lunch Bx

by New England Medical Instruments, Inc.

510(k) K910771

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910771 Date18 Dec 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Digitrace(Tm) Home Monit Comp/Elb(Tm) EEG Lunch Bx
510(k) Number
FDA Product Code
OMB
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Automatic Event Detection Software For Full-Montage Electroencephalograph. It is designed for use in neurology applications.

It is supplied as a software component for electroencephalograph systems. The device received FDA 510(k) clearance through a traditional submission process and is classified as a Class II medical device.

Other devices from New England Medical Instruments, Inc.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX used for?

    This device is an Automatic Event Detection Software For Full-Montage Electroencephalograph designed for use in neurology applications. It analyzes EEG data to automatically detect specific neurological events, supporting clinical assessment in neurology settings.

  • How is the DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX supplied and what is its format?

    The device is supplied as a software component intended for integration into electroencephalograph systems. It is not a physical hardware device but a software module that works with full-montage EEG equipment to provide automatic event detection capabilities.

  • Is the DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX a single-use or reusable device?

    As a software component, the device is reusable in the sense that it can be installed and used repeatedly on compatible EEG systems. It does not have physical consumable parts and is not classified as single-use; its reuse depends on the host EEG system's operational lifecycle and software licensing terms.