Cleared Traditional

K830702 - NICOLET EMG SATELLITE

K830702 is an FDA 510(k) clearance for NICOLET EMG SATELLITE, manufactured by Nicolet Biomedical Instruments. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K830702 · Nicolet Biomedical Instruments · Neurology device
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Jul 1983
Decision
127d
Days
Class 2
Risk

K830702 is an FDA 510(k) clearance for the NICOLET EMG SATELLITE. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Nicolet Biomedical Instruments (Walker, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 Nicolet Biomedical Instruments devices

FDA 510(k) Submission Details - K830702

510(k) Number K830702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1983
Decision Date July 12, 1983
Days to Decision 127 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
21d faster than avg
Panel avg: 148d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 40
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K830702.
CA2000
K842611 · Nicolet Biomedical Instruments · Jul 1984
COMPACT AUDITORY
K842612 · Nicolet Biomedical Instruments · Jul 1984
COMPACT VISUAL
K842613 · Nicolet Biomedical Instruments · Jul 1984
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K822624 · Del Mar Avionics · Oct 1982
ANESTHESIA & BRAIN MONITOR
K821910 · Datex Division Instrumentarium Corp. · Sep 1982