← Product Code [HMJ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMJ) · K934084

# BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (K934084)

_Bioenterics Corp. · HMJ · Dec 16, 1993 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMJ/K934084

## Device Facts

- **Applicant:** Bioenterics Corp.
- **Product Code:** [HMJ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMJ.md)
- **Decision Date:** Dec 16, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1810
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMJ/K934084](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HMJ/K934084)

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