Cleared Traditional

K000288 - REICHERT CT200 CONTACT TONOMETER
(FDA 510(k) Clearance)

K000288 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Ophthalmic device

Mar 2000

Decision

52d

Days

Class 2

Risk

K000288 is an FDA 510(k) clearance for the REICHERT CT200 CONTACT TONOMETER. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).

Submitted by Reichert Ophthalmic Instruments, Div. Leica, Inc. (Depew, US). The FDA issued a Cleared decision on March 23, 2000, 52 days after receiving the submission on January 31, 2000.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K000288 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 2000
Decision Date	March 23, 2000
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement