Cleared Traditional

CATS Tonometer Prism

K173904 · Cats Tonometer, LLC · Ophthalmic
Mar 2018
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K173904 is an FDA 510(k) clearance for the CATS Tonometer Prism, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Cats Tonometer, LLC (Tucson, US). The FDA issued a Cleared decision on March 9, 2018, 77 days after receiving the submission on December 22, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K173904 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2017
Decision Date March 09, 2018
Days to Decision 77 days
Submission Type Traditional
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