Cleared Abbreviated

KEELER SLIT LAMP H-SERIES

K131589 · Keeler, Ltd. · Ophthalmic
Jun 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K131589 is an FDA 510(k) clearance for the KEELER SLIT LAMP H-SERIES, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Keeler, Ltd. (Windsor, Berkshire, GB). The FDA issued a Cleared decision on June 27, 2013, 27 days after receiving the submission on May 31, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K131589 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2013
Decision Date June 27, 2013
Days to Decision 27 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

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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