Cleared Traditional

EEG NEUROAMP, MODEL CS10137 (K073557) - FDA 510(k) Clearance

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

K073557 · Corscience GmbH & Co. KG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
71d
Days
Class 2
Risk

K073557 is an FDA 510(k) clearance for the EEG NEUROAMP, MODEL CS10137. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Corscience GmbH & Co. KG (Erlangen, Bavaria, DE). The FDA issued a Cleared decision on February 28, 2008 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Corscience GmbH & Co. KG devices

Submission Details

510(k) Number K073557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2007
Decision Date February 28, 2008
Days to Decision 71 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
77d faster than avg
Panel avg: 148d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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.