Cleared Traditional

HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER

K891610 · Keeler Instruments, Inc. · Ophthalmic
Jun 1989
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K891610 is an FDA 510(k) clearance for the HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER, a Clamp, Eyelid, Ophthalmic (Class I — General Controls, product code HOD), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 5, 1989, 77 days after receiving the submission on March 20, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K891610 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1989
Decision Date June 05, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HOD — Clamp, Eyelid, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350