Cleared Traditional

A O CUSTOM II CHAIR AND STAND

K801638 · American Optical Corp. · Ophthalmic
Aug 1980
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K801638 is an FDA 510(k) clearance for the A O CUSTOM II CHAIR AND STAND, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980, 27 days after receiving the submission on July 17, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number K801638 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1980
Decision Date August 13, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HME — Chair, Ophthalmic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1140

Similar Devices — HME Chair, Ophthalmic, Ac-powered

All 15
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
K930449 · Marco Ophthalmic, Inc. · Jul 1993
BREATH-EASY, MODIFICATION
K914416 · Icor AB · Jun 1992
RELIANCE(R) 6200 EXAMINATION CHAIR
K894018 · Reliance Medical Products, Inc. · Sep 1989
STORZ ENT/OPHTHALMIC MAXI CHAIR
K870112 · Storz Instrument Co. · Feb 1987
MODEL 6500 OPTHALMIC CHAIR
K864494 · Koken Mfg Company, Inc. · Dec 1986
MAC 150E OPTHALMIC CHAIR
K864574 · Koken Mfg Company, Inc. · Dec 1986