Cleared Special

D-KAT Z-YPE

K142179 · Keeler, Ltd. · Ophthalmic
Sep 2014
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K142179 is an FDA 510(k) clearance for the D-KAT Z-YPE, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Keeler, Ltd. (Broomall, US). The FDA issued a Cleared decision on September 17, 2014, 40 days after receiving the submission on August 8, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K142179 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2014
Decision Date September 17, 2014
Days to Decision 40 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKY — Tonometer, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930