21 CFR 886.1460 — Instrument, Measuring, Stereopsis

Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1460

Identification

A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.

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 the limitations in § 886.9. 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