21 CFR 882.1200 — Discriminator, Two-Point
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1200
Identification
A two-point discriminator is a device with points used for testing a patient's touch discrimination.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWI | Discriminator, Two-Point | 1 | 2 | |
| LLN | Device, Vibration Threshold Measurement | 1 | 13 | |
| LQW | Test, Temperature Discrimination | 1 | 3 |
