Cleared Traditional

KEELER/KONAN SPECULAR MICROSCOPE

K810403 · Keeler Optical Products , Ltd. · Ophthalmic
May 1981
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K810403 is an FDA 510(k) clearance for the KEELER/KONAN SPECULAR MICROSCOPE, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Keeler Optical Products , Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1981, 84 days after receiving the submission on February 18, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K810403 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1981
Decision Date May 13, 1981
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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