Cleared Traditional

BRAEGEN III 10-CHANNEL TRANSMITTER- (K832304) - FDA 510(k) Clearance

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

K832304 · Electro-Bio-Medical Services, Inc. · Neurology device
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Aug 1983
Decision
48d
Days
Class 2
Risk

K832304 is an FDA 510(k) clearance for the BRAEGEN III 10-CHANNEL TRANSMITTER-. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Electro-Bio-Medical Services, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1855 - 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 Electro-Bio-Medical Services, Inc. devices

Submission Details

510(k) Number K832304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1983
Decision Date August 31, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 148d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYE Encephalogram Telemetry System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1855
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.