Cleared Traditional

CERSR ELECTROMYOGRAPHY SYSTEM (K990766) - FDA 510(k) Clearance

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

K990766 · Paraspinal Diagnostic Corp. · Neurology device
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Aug 1999
Decision
172d
Days
Class 2
Risk

K990766 is an FDA 510(k) clearance for the CERSR ELECTROMYOGRAPHY SYSTEM. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Paraspinal Diagnostic Corp. (Rockville, US). The FDA issued a Cleared decision on August 27, 1999 after a review of 172 days - an extended review cycle.

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 Paraspinal Diagnostic Corp. devices

Submission Details

510(k) Number K990766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date August 27, 1999
Days to Decision 172 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
24d slower than avg
Panel avg: 148d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.