Cleared Traditional

INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV

K951338 · Neitz Instruments Company, Ltd. · Ophthalmic
Apr 1995
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K951338 is an FDA 510(k) clearance for the INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on April 7, 1995, 14 days after receiving the submission on March 24, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K951338 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1995
Decision Date April 07, 1995
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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