Cleared Traditional

K180839 - AT 030 (FDA 510(k) Clearance)

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

K180839 is an FDA 510(k) clearance for the AT 030. This device is classified as 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 FDA review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K180839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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