Cleared Traditional

PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM

K881358 · Neuroscientific Corp. · Ophthalmic

Jun 1988

Decision

88d

Days

Class 1

Risk

About This 510(k) Submission

K881358 is an FDA 510(k) clearance for the PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Neuroscientific Corp. (Farmingdale, US). The FDA issued a Cleared decision on June 27, 1988, 88 days after receiving the submission on March 31, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number	K881358 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 1988
Decision Date	June 27, 1988
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—