Cleared Traditional

AT 030

K180839 · Carl Zeiss Meditec, AG · Ophthalmic
Jun 2018
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K180839 is an FDA 510(k) clearance for the AT 030, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on June 7, 2018, 69 days after receiving the submission on March 30, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K180839 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2018
Decision Date June 07, 2018
Days to Decision 69 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