Cleared Traditional

K812706 - MILLER/NADLER GLARE TESTER
(FDA 510(k) Clearance)

Nov 1981
Decision
53d
Days
Class 1
Risk

K812706 is an FDA 510(k) clearance for the MILLER/NADLER GLARE TESTER. This device is classified as a Projector, Ophthalmic (Class I - General Controls, product code HOS).

Submitted by Mosebach Electric & Supply (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981, 53 days after receiving the submission on September 24, 1981.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1680.

Submission Details

510(k) Number K812706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1981
Decision Date November 16, 1981
Days to Decision 53 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HOS — Projector, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1680

Similar Devices — HOS Projector, Ophthalmic

All 8
WIRELESS CHART PROJECTOR,HCP-W 721
K936200 · Canon USA, Inc. · Sep 1994
MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE
K930443 · Marco Ophthalmic, Inc. · Jul 1993
BURTON PROJECTOR HEAD - MODEL 6000-H
K924784 · R.H. Burton Co. · Apr 1993
OPHTHALMIC PROJECTOR
K921214 · Luneau Ophtalmologie SA · Jun 1992
WOODLYN OPHTHALMIC PROJECTOR
K890992 · Woodlyn, Inc. · May 1989
BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR
K862519 · Bausch & Lomb, Inc. · Jul 1986