Cleared Traditional

ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ

K811180 · American Optical Corp. · Ophthalmic
May 1981
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K811180 is an FDA 510(k) clearance for the ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ, a Projector, Ophthalmic (Class I — General Controls, product code HOS), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981, 17 days after receiving the submission on April 28, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1680.

Submission Details

510(k) Number K811180 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1981
Decision Date May 15, 1981
Days to Decision 17 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