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K Number
K970436
Device Name
E-READER
Manufacturer
NATURAL HERBAL PRODUCTS, INC.
Date Cleared
1997-08-15

(191 days)

Product Code
GZO,84G
Regulation Number
882.1540
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Galvanic Skin Resistance Measurement

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "E-Reader". It only indicates that the device is a "Galvanic Skin Resistance Measurement" device and is substantially equivalent to a pre-amendment device.

This document does not contain any information regarding:

  • Acceptance criteria or reported device performance
  • Details of any study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).

Therefore, I cannot fulfill your request for a description of acceptance criteria and the study that proves the device meets them based on the provided text.

§ 882.1540 Galvanic skin response measurement device.

(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.