← Product Code [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX) · K945972

# DIGITAL AVERAGING TONOMETER (K945972)

_Opti-Med Electronics · HKX · Aug 17, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K945972

## Device Facts

- **Applicant:** Opti-Med Electronics
- **Product Code:** [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX.md)
- **Decision Date:** Aug 17, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1930
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K945972](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K945972)

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