Cleared Traditional

K883112 - DERMATRON SKIN RESISTANCE METER

K883112 is an FDA 510(k) clearance for DERMATRON SKIN RESISTANCE METER, manufactured by Raymar Electronics. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K883112 · Raymar Electronics · Neurology device
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Aug 1989
Decision
381d
Days
Class 2
Risk

K883112 is an FDA 510(k) clearance for the DERMATRON SKIN RESISTANCE METER. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Raymar Electronics (Oxon Rg9 1ll, England, GB). The FDA issued a Cleared decision on August 10, 1989 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1540 - 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. Elevated predicate reliance profile. 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 Raymar Electronics devices

FDA 510(k) Submission Details - K883112

510(k) Number K883112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1988
Decision Date August 10, 1989
Days to Decision 381 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 148d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZO Device Classification - Class 2, Special Controls

Product Code GZO Device, Galvanic Skin Response Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1540
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.