Cleared Traditional

K832142 - DICON GLAUCOMA DIAG. CENTER 2000 SERIES (FDA 510(k) Clearance)

Aug 1983
Decision
27d
Days
Class 1
Risk

K832142 is an FDA 510(k) clearance for the DICON GLAUCOMA DIAG. CENTER 2000 SERIES. This device is classified as a Perimeter, Automatic, Ac-powered (Class I - General Controls, product code HPT).

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1983, 27 days after receiving the submission on July 5, 1983.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number K832142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1983
Decision Date August 01, 1983
Days to Decision 27 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