Cleared Traditional

K913604 - SOMATOSENSORY STIMULUS SYSTEM

K913604 is an FDA 510(k) clearance for SOMATOSENSORY STIMULUS SYSTEM, manufactured by Biomagnetic Technologies, Inc.. The device is a Class 2 Neurology device with product code GZP cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K913604 · Biomagnetic Technologies, Inc. · Neurology device
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Dec 1991
Decision
117d
Days
Class 2
Risk

K913604 is an FDA 510(k) clearance for the SOMATOSENSORY STIMULUS SYSTEM. Classified as Stimulator, Mechanical, Evoked Response (product code GZP), Class II - Special Controls.

Submitted by Biomagnetic Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1880 - 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 Biomagnetic Technologies, Inc. devices

FDA 510(k) Submission Details - K913604

510(k) Number K913604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1991
Decision Date December 09, 1991
Days to Decision 117 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
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZP Device Classification - Class 2, Special Controls

Product Code GZP Stimulator, Mechanical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1880
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.