Cleared Traditional

Microperimeter MP-3, Microperimeter MP-3 Type S

K190198 · Nidek Co., Ltd. · Ophthalmic
Apr 2019
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K190198 is an FDA 510(k) clearance for the Microperimeter MP-3, Microperimeter MP-3 Type S, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on April 1, 2019, 56 days after receiving the submission on February 4, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K190198 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2019
Decision Date April 01, 2019
Days to Decision 56 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120