Cleared Traditional

K843004 - SERVO MED NYSTAGMOGRAPH NG-1

K843004 is the FDA 510(k) clearance for SERVO MED NYSTAGMOGRAPH NG-1 by Servo Med, Inc.. It is a Class 2 Neurology device (product code GWN) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K843004 · Servo Med, Inc. · Neurology device
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Oct 1984
Decision
92d
Days
Class 2
Risk

K843004 is an FDA 510(k) clearance for the SERVO MED NYSTAGMOGRAPH NG-1. Classified as Nystagmograph (product code GWN), Class II - Special Controls.

Submitted by Servo Med, Inc. (Greenwich, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1460 - 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 Servo Med, Inc. devices

Submission Details

510(k) Number K843004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date October 30, 1984
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWN Nystagmograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1460
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 - GWN Nystagmograph

All 16
Devices cleared under the same product code (GWN) and FDA review panel - the closest regulatory comparables to K843004.
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · Life-Tech Intl., Inc. · Jun 1992
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · Oxford Medilog, Inc. · Apr 1986
ELECTRONYSTAGMOGRAPH (ENG RECORDER)
K850180 · Bio-Logic Systems Corp. · Jul 1985
NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH
K822268 · Kelleher Corp. · Jan 1983
NAGASHIMA KN-52 SACCADE & PURSUIT STIM
K822266 · Kelleher Corp. · Aug 1982