21 CFR 886.1940 — Sterilizer, Tonometer
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1940
Identification
A tonometer sterilizer is an AC-powered device intended to heat sterilize a tonometer (a device used to measure intraocular pressure).
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 § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HKZ | Sterilizer, Tonometer | 1 | 0 |
