Cleared Traditional

K003154 - MIZAR, BASIS BE, SANDMAN DIGITAL (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003154 · Eb Neuro S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
87d
Days
Class 2
Risk

K003154 is an FDA 510(k) clearance for the MIZAR, BASIS BE, SANDMAN DIGITAL. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Eb Neuro S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on January 5, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1835 - 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 Eb Neuro S.P.A. devices

Submission Details

510(k) Number K003154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date January 05, 2001
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWL Amplifier, Physiological Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1835
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 - GWL Amplifier, Physiological Signal

All 52
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