Cleared Traditional

MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR

K930449 · Marco Ophthalmic, Inc. · Ophthalmic
Jul 1993
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K930449 is an FDA 510(k) clearance for the MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 6, 1993, 161 days after receiving the submission on January 26, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number K930449 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date July 06, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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