Cleared Traditional

K970672 - CRYSTAL-EEG MODEL 10 (MODEL 10) (FDA 510(k) Clearance)

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

K970672 · Cleveland Medical Devices, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
87d
Days
Class 2
Risk

K970672 is an FDA 510(k) clearance for the CRYSTAL-EEG MODEL 10 (MODEL 10). Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Cleveland Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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 Cleveland Medical Devices, Inc. devices

Submission Details

510(k) Number K970672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date May 22, 1997
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 OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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 - OMC Reduced- Montage Standard Electroencephalograph

All 27
Devices cleared under the same product code (OMC) and FDA review panel - the closest regulatory comparables to K970672.
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