← Product Code [HKY](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY) · K882750

# OCU-FILM TIP COVER (K882750)

_Oculab, Inc. · HKY · Aug 4, 1988 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K882750

## Device Facts

- **Applicant:** Oculab, Inc.
- **Product Code:** [HKY](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY.md)
- **Decision Date:** Aug 4, 1988
- **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/HKY/K882750](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKY/K882750)

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