Cleared Traditional

K001324 - SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)

K001324 is an FDA 510(k) clearance for SYNAMPS (32-64 CHANNELS), manufactured by Neuro Scan Labs. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K001324 · Neuro Scan Labs · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
76d
Days
Class 2
Risk

K001324 is an FDA 510(k) clearance for the SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256.... Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Neuro Scan Labs (El Paso, US). The FDA issued a Cleared decision on July 11, 2000 after a review of 76 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 Neuro Scan Labs devices

FDA 510(k) Submission Details - K001324

510(k) Number K001324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date July 11, 2000
Days to Decision 76 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
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For 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.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 31
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