Cleared Traditional

K955787 - DIGITRACE HOME VIDEO SYSTEM

K955787 is an FDA 510(k) clearance for DIGITRACE HOME VIDEO SYSTEM, manufactured by New England Medical Instruments, Inc.. The device is a Class 2 Neurology device with product code OMB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K955787 · New England Medical Instruments, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
50d
Days
Class 2
Risk

K955787 is an FDA 510(k) clearance for the DIGITRACE HOME VIDEO SYSTEM. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by New England Medical Instruments, Inc. (Boston, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New England Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K955787

510(k) Number K955787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date February 09, 1996
Days to Decision 50 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMB Device Classification - Class 2, Special Controls

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 32
Devices cleared under the same product code (OMB) and FDA review panel - the closest regulatory comparables to K955787.
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
K010085 · Excel Tech. , Ltd. · Mar 2001
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · Excel Tech. , Ltd. · Oct 2000
HARMONIE SENSA
K960273 · Stellate Systems · Apr 1996
BIO-LOGIC AUTOMATIC EVENT ANALYSIS
K951594 · Bio-Logic Systems Corp. · Aug 1995