Cleared Traditional

AUTOMATED PERIMETERS

K803159 · Coburn Optical Ind., Inc. · Ophthalmic
Feb 1981
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K803159 is an FDA 510(k) clearance for the AUTOMATED PERIMETERS, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981, 58 days after receiving the submission on December 8, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number K803159 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1980
Decision Date February 04, 1981
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPT — Perimeter, Automatic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1605

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