Cleared Traditional

K182199 - NFC-700 non-mydriatic auto fundus camera (FDA 510(k) Clearance)

K182199 · Crystalvue Medical Corporation · Ophthalmic device

Jan 2019

Decision

141d

Days

Class 2

Risk

K182199 is an FDA 510(k) clearance for the NFC-700 non-mydriatic auto fundus camera. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).

Submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on January 2, 2019, 141 days after receiving the submission on August 14, 2018.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K182199 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 14, 2018
Decision Date	January 02, 2019
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF