Cleared Traditional

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2

K944207 · Computed Anatomy, Inc. · Ophthalmic

Dec 1994

Decision

100d

Days

Class 1

Risk

About This 510(k) Submission

K944207 is an FDA 510(k) clearance for the TOPOGRAPHIC MODELING SYSTEM 2 TMS-2, a Keratoscope, Ac-powered (Class I — General Controls, product code HLQ), submitted by Computed Anatomy, Inc. (New York, US). The FDA issued a Cleared decision on December 7, 1994, 100 days after receiving the submission on August 29, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1350.

Submission Details

510(k) Number	K944207 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 1994
Decision Date	December 07, 1994
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF