Cleared Traditional

K030719 - PENTACAM SCHEIMPFLUG CAMERA
(FDA 510(k) Clearance)

K030719 · Oculus Optikgerate GmbH · Ophthalmic
Sep 2003
Decision
193d
Days
Class 2
Risk

K030719 is an FDA 510(k) clearance for the PENTACAM SCHEIMPFLUG CAMERA. This device is classified as a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK).

Submitted by Oculus Optikgerate GmbH (Woodinville, US). The FDA issued a Cleared decision on September 16, 2003, 193 days after receiving the submission on March 7, 2003.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K030719 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2003
Decision Date September 16, 2003
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MXK — Device, Analysis, Anterior Segment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850