Cleared Traditional

K881177 - MODEL MEB-5304 EVOKED POTENTIAL & ELECT...

K881177 is an FDA 510(k) clearance for MODEL MEB-5304 EVOKED POTENTIAL & ELECT..., manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Neurology device with product code GWL cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K881177 · Nihon Kohden America, Inc. · Neurology device
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Sep 1988
Decision
196d
Days
Class 2
Risk

K881177 is an FDA 510(k) clearance for the MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD. Classified as Amplifier, Physiological Signal (product code GWL), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K881177

510(k) Number K881177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date September 30, 1988
Days to Decision 196 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 148d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWL Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (GWL) and FDA review panel - the closest regulatory comparables to K881177.
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