Cleared Traditional

K792085 - C-ERA-100 COMPUTERIZED ELECTRIC RESPON

K792085 is the FDA 510(k) clearance for C-ERA-100 COMPUTERIZED ELECTRIC RESPON by Micro-Shev , Ltd.. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K792085 · Micro-Shev , Ltd. · Neurology device
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Oct 1979
Decision
13d
Days
Class 2
Risk

K792085 is an FDA 510(k) clearance for the C-ERA-100 COMPUTERIZED ELECTRIC RESPON. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Micro-Shev , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1979 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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.

View all Micro-Shev , Ltd. devices

Submission Details

510(k) Number K792085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1979
Decision Date October 30, 1979
Days to Decision 13 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d faster than avg
Panel avg: 148d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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.