Device Name
GSA GENITO SENSORY ANALYZERManufacturer
Date Cleared
2001-09-20
(171 days)
Product Code
Regulation Number
882.1200Type
TraditionalPanel
NeurologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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§ 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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.