Cleared Traditional

K970436 - E-READER

K970436 is an FDA 510(k) clearance for E-READER, manufactured by Natural Herbal Products, Inc.. The device is a Class 2 Neurology device with product code GZO cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K970436 · Natural Herbal Products, Inc. · Neurology device
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Aug 1997
Decision
191d
Days
Class 2
Risk

K970436 is an FDA 510(k) clearance for the E-READER. Classified as Device, Galvanic Skin Response Measurement (product code GZO), Class II - Special Controls.

Submitted by Natural Herbal Products, Inc. (Naples, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 191 days - an extended review cycle.

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. 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.

FDA 510(k) Submission Details - K970436

510(k) Number K970436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1997
Decision Date August 15, 1997
Days to Decision 191 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 149d · This submission: 191d
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.

Regulatory Peers - GZO Device, Galvanic Skin Response Measurement

All 24
Devices cleared under the same product code (GZO) and FDA review panel - the closest regulatory comparables to K970436.
MSAS PROFESSIONAL
K993824 · Biomeridian, Int. · Jan 2000
EIM-107 PREP-CHECK
K993202 · General Devices · Dec 1999
PHAZX VLD-100
K992129 · Phazx Systems, Inc. · Sep 1999
GALVANIC SKIN RESPONSE DEVICE
K943101 · Global Ent. · Oct 1995
DERMATRON SKIN RESISTANCE METER
K883112 · Raymar Electronics · Aug 1989
EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER
K874850 · Epi-Scan Corp. · May 1988
K970436 · E-READER
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