Cleared Traditional

EYECHEK

K964290 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Ophthalmic

Jan 1997

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K964290 is an FDA 510(k) clearance for the EYECHEK, a Keratoscope, Ac-powered (Class I — General Controls, product code HLQ), submitted by Reichert Ophthalmic Instruments, Div. Leica, Inc. (Depew, US). The FDA issued a Cleared decision on January 9, 1997, 73 days after receiving the submission on October 28, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1350.

Submission Details

510(k) Number	K964290 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 1996
Decision Date	January 09, 1997
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement