MERIDIAN-II AND MERDIAN-PLUS

• K Number: K001347
• Device Name: MERIDIAN-II AND MERDIAN-PLUS
• Manufacturer: MERIDIAN CO., LTD.
• Date Cleared: 2000-11-03 ( 189 days)
• Product Code: GZO
• Regulation Number: 882.1540

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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