Cleared Traditional

GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES

K093213 · Carl Zeiss Meditec, Inc. · Ophthalmic

Mar 2010

Decision

150d

Days

Class 1

Risk

About This 510(k) Submission

K093213 is an FDA 510(k) clearance for the GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on March 12, 2010, 150 days after receiving the submission on October 13, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number	K093213 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2009
Decision Date	March 12, 2010
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF