Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart B - Neurological Diagnostic Devices / § 882.1200 Two-point discriminator.
§ 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.