GSA GENITO SENSORY ANALYZER

• K Number: K010981
• Device Name: GSA GENITO SENSORY ANALYZER
• Manufacturer: MEDOC LTD. ADVANCED MEDICAL SYSTEMS
• Date Cleared: 2001-09-20 ( 171 days)
• Product Code: LLN
• Regulation Number: 882.1200

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

§ 882.1200 Two-point discriminator.

(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.

Summary

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