21 CFR 882.1500 — Esthesiometer

Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1500

Identification

An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.

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