Cleared Traditional

K060997 - SNAP II EEG MONITOR

K060997 is an FDA 510(k) clearance for SNAP II EEG MONITOR, manufactured by Everest Biomedical Instruments Co.. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K060997 · Everest Biomedical Instruments Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
66d
Days
Class 2
Risk

K060997 is an FDA 510(k) clearance for the SNAP II EEG MONITOR. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Everest Biomedical Instruments Co. (Chesterfield, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 66 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 Everest Biomedical Instruments Co. devices

FDA 510(k) Submission Details - K060997

510(k) Number K060997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date June 15, 2006
Days to Decision 66 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 148d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLW Device Classification - Class 2, Special Controls

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A 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.

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All 14
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