Cleared Traditional

NIDEK DIGITAL KERATOMETER

K842892 · Nidek, Inc. · Ophthalmic

Oct 1984

Decision

74d

Days

Class 3

Risk

About This 510(k) Submission

K842892 is an FDA 510(k) clearance for the NIDEK DIGITAL KERATOMETER, a Intraocular Lens (Class III — Premarket Approval, product code HQL), submitted by Nidek, Inc. (Walker, US). The FDA issued a Cleared decision on October 5, 1984, 74 days after receiving the submission on July 23, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3600.

Submission Details

510(k) Number	K842892 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1984
Decision Date	October 05, 1984
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—