Cleared Traditional

DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES (K883461) - FDA 510(k) Clearance

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

K883461 · Biohm, Inc. · Neurology device
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Nov 1988
Decision
110d
Days
Class 2
Risk

K883461 is an FDA 510(k) clearance for the DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES. Classified as Encephalogram Telemetry System (product code GYE), Class II - Special Controls.

Submitted by Biohm, Inc. (Boulder, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 110 days - within the typical 510(k) review window.

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: 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 Biohm, Inc. devices

Submission Details

510(k) Number K883461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1988
Decision Date November 30, 1988
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
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.