Cleared Traditional

NEITZ SLIT LAMP SL-H1

K951340 · Neitz Instruments Company, Ltd. · Ophthalmic
Apr 1995
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K951340 is an FDA 510(k) clearance for the NEITZ SLIT LAMP SL-H1, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on April 10, 1995, 17 days after receiving the submission on March 24, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K951340 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1995
Decision Date April 10, 1995
Days to Decision 17 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

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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