Cleared Traditional

TRUEFIELD ANALYZER

K063310 · Seeing Machines Limited · Ophthalmic

Aug 2007

Decision

273d

Days

Class 1

Risk

About This 510(k) Submission

K063310 is an FDA 510(k) clearance for the TRUEFIELD ANALYZER, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Seeing Machines Limited (San Diego, US). The FDA issued a Cleared decision on August 2, 2007, 273 days after receiving the submission on November 2, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number	K063310 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2006
Decision Date	August 02, 2007
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF