Cleared Traditional

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

K013694 · Nidek, Inc. · Ophthalmic

Nov 2002

Decision

377d

Days

Class 2

Risk

About This 510(k) Submission

K013694 is an FDA 510(k) clearance for the NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS), a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 19, 2002, 377 days after receiving the submission on November 7, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K013694 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 2001
Decision Date	November 19, 2002
Days to Decision	377 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF