Cleared Traditional

Keeler TonoCare Tonometer

K181143 · Keeler Instruments, Inc. · Ophthalmic
Feb 2019
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K181143 is an FDA 510(k) clearance for the Keeler TonoCare Tonometer, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Keeler Instruments, Inc. (Malvern, US). The FDA issued a Cleared decision on February 8, 2019, 283 days after receiving the submission on May 1, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K181143 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2018
Decision Date February 08, 2019
Days to Decision 283 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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