Cleared Traditional

THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

K050350 · Notal Vision, Inc. · Ophthalmic

Apr 2005

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K050350 is an FDA 510(k) clearance for the THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP), a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Notal Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on April 29, 2005, 77 days after receiving the submission on February 11, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number	K050350 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2005
Decision Date	April 29, 2005
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF