Cleared Traditional

TOMEY EM-1000 SPECULAR MICROSCOPE

K944910 · Tomey Corporation USA · Ophthalmic
Nov 1994
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K944910 is an FDA 510(k) clearance for the TOMEY EM-1000 SPECULAR MICROSCOPE, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Tomey Corporation USA (Rockville, US). The FDA issued a Cleared decision on November 22, 1994, 48 days after receiving the submission on October 5, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K944910 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1994
Decision Date November 22, 1994
Days to Decision 48 days
Submission Type Traditional
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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