Cleared Abbreviated

KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)

K093445 · Keeler, Ltd. · Ophthalmic

Jan 2010

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K093445 is an FDA 510(k) clearance for the KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT), a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Keeler, Ltd. (Broomall, US). The FDA issued a Cleared decision on January 19, 2010, 90 days after receiving the submission on October 21, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K093445 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2009
Decision Date	January 19, 2010
Days to Decision	90 days
Submission Type	Abbreviated
Review Panel	Ophthalmic (OP)
Summary	Summary PDF