Cleared Traditional

K913785 - CORONET 100

K913785 is the FDA 510(k) clearance for CORONET 100 by Micro-Shev , Ltd.. It is a Class 2 Neurology device (product code GWJ) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K913785 · Micro-Shev , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
130d
Days
Class 2
Risk

K913785 is an FDA 510(k) clearance for the CORONET 100. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Micro-Shev , Ltd. (Efrat, IL). The FDA issued a Cleared decision on December 31, 1991 after a review of 130 days - within the typical 510(k) review window.

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: 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 Micro-Shev , Ltd. devices

Submission Details

510(k) Number K913785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date December 31, 1991
Days to Decision 130 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 148d · This submission: 130d
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.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 20
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K913785.
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999
BIO-LOGIC EVOKED POTENTIAL FOR ABAER I
K992807 · Bio-Logic Systems Corp. · Sep 1999
EXCEL AV STIM 1000
K972157 · Excel Tech. , Ltd. · Jan 1998
TECA/MEDELEC AS-10 SENSOR
K862906 · Teca, Inc. · Feb 1987
TECA/MEDELEC AUDIOSTAR
K863156 · Teca, Inc. · Feb 1987
EVOPORT 100
K863985 · Jedmed Instrument Co. · Jan 1987