Cleared Traditional

K014044 - MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
(FDA 510(k) Clearance)

K014044 · Notal Vision, Inc. · Ophthalmic
Mar 2002
Decision
87d
Days
Class 1
Risk

K014044 is an FDA 510(k) clearance for the MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT), a Grid, Amsler (Class I — General Controls, product code HOQ), submitted by Notal Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on March 4, 2002, 87 days after receiving the submission on December 7, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1330.

Submission Details

510(k) Number K014044 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2001
Decision Date March 04, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HOQ — Grid, Amsler
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1330