Cleared Traditional

K073557 - EEG NEUROAMP, MODEL CS10137

K073557 is an FDA 510(k) clearance for EEG NEUROAMP, manufactured by Corscience GmbH & Co. KG. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K073557 · Corscience GmbH & Co. KG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K073557

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 149d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HCC Device, Biofeedback

All 171
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K073557.
EEGER4 MODEL 4.3
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GRINDCARE
K092675 · Medotech A/S · Mar 2010
NTRAINER SYSTEM
K071866 · Kcbiomedix, Inc. · Feb 2008
ALPHAONE BIOFEEDBACK SYSTEM
K071661 · Telediagnostic Systems, Inc. · Sep 2007
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
K073557 · EEG NEUROAMP, MODEL CS10137
Download PDF FDA Summary Corscience GmbH & Co.…