HKZ · Sterilizer, Tonometer
Ophthalmic · 21 CFR 886.1940 · Class 1
Overview
| Product Code | HKZ |
|---|---|
| Device Name | Sterilizer, Tonometer |
| Regulation | 21 CFR 886.1940 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
