Cleared Traditional

NON-CONTACT TONOMETER, MODEL FT-1000

K073087 · Tomey Corporation · Ophthalmic
Nov 2008
Decision
383d
Days
Class 2
Risk

About This 510(k) Submission

K073087 is an FDA 510(k) clearance for the NON-CONTACT TONOMETER, MODEL FT-1000, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Tomey Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 18, 2008, 383 days after receiving the submission on November 1, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K073087 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2007
Decision Date November 18, 2008
Days to Decision 383 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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