Cleared Traditional

ROTA SYSTEM XL

K931839 · Rota Systems Medfurniture, Inc. · Ophthalmic

Nov 1993

Decision

223d

Days

Class 1

Risk

About This 510(k) Submission

K931839 is an FDA 510(k) clearance for the ROTA SYSTEM XL, a Stand, Instrument, Ac-powered, Ophthalmic (Class I — General Controls, product code HMF), submitted by Rota Systems Medfurniture, Inc. (Derby, US). The FDA issued a Cleared decision on November 22, 1993, 223 days after receiving the submission on April 13, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1860.

Submission Details

510(k) Number	K931839 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 1993
Decision Date	November 22, 1993
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement