Cleared Traditional

NON-CONTACT TONOMETER, MODEL NT-4000

K031733 · Nidek, Inc. · Ophthalmic
Dec 2003
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K031733 is an FDA 510(k) clearance for the NON-CONTACT TONOMETER, MODEL NT-4000, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on December 4, 2003, 183 days after receiving the submission on June 4, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K031733 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2003
Decision Date December 04, 2003
Days to Decision 183 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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